Medtronic Announces Voluntary Recall of Unused Valiant Navion Thoracic Stent Graft System

Medtronic plc (NYSE:MDT), the global leader in medical technology, has voluntarily issued a global recall of unused Medtronic Valiant Navion™ thoracic stent graft system and informed physicians to immediately cease use of the device until further notice.

In accordance with its commitment to patient safety – and in consultation with independent physicians – Medtronic initiated this action in response to information recently obtained from the Valiant Evo Global Clinical Trial indicating that three patients in the Valiant Evo Global Clinical Trial were observed to have stent fractures, two of which have confirmed type IIIb endoleaks. One patient death was reported.

Following these observations, an independent imaging laboratory reviewed all available images from patients enrolled in the Valiant Evo Global Clinical Trial. Upon further analysis of the images, seven (7) out of 87 patients were observed to have stent ring enlargement beyond the design specification. Those observations require further assessment to determine potential clinical importance.

Medtronic is currently conducting a comprehensive technical root cause investigation, including further review of follow-up clinical trial imaging and commercial complaints and imaging.

"There is nothing more important than the safety and well-being of patients," said Nina Goodheart , senior vice president and president, Structural Heart & Aortic, which is reported as part of the Cardiac Vascular Group at Medtronic. "We treat matters of product safety with the highest priority and urgency. Our decision to implement this voluntary recall is necessary to ensure the utmost patient safety. As our investigation continues, we are committed to timely communication with physicians and regulatory bodies."

Medtronic has contacted the U.S. Food and Drug Administration (FDA), along with other regulatory bodies around the world, to share information related to this issue. Medtronic will continue working directly with regulatory authorities on this global voluntary recall.

Patient Management Recommendations
Patients with a Medtronic Valiant Navion thoracic stent graft system should consult their physician with any questions.

As part of the voluntary recall of unused product, physicians were sent written communication from Medtronic directing them to immediately cease use of the Medtronic Valiant Navion thoracic stent graft system and instructions for returning unused product to Medtronic.

Medtronic advises physicians to retrospectively review all available images of patients treated with Valiant Navion thoracic stent graft system with specific attention to stent fractures and type IIIb endoleaks and contact Medtronic if any imaging findings are observed.

Medtronic urges physicians to follow best clinical practices and evaluate patients with at least annual follow-up according to the imaging recommendations in the Medtronic Valiant Navion thoracic stent graft system Instructions for Use (IFU).

As always, physicians are asked to notify Medtronic of any adverse events or product safety issues associated with use of any Medtronic product, which also should be reported to the FDA's MedWatch Adverse Event Reporting program. Outside of the U.S. adverse events or product safety issues associated with use of any Medtronic product should be reported to the appropriate competent authority.

About Medtronic
Medtronic plc ( www.medtronic.com ), headquartered in Dublin, Ireland , is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contacts:
Ben Petok	Ryan Weispfenning
Public Relations	Investor Relations
+1-612-297-0501	+1-763-505-4626

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SOURCE Medtronic plc

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MEDTRONIC PLC WORLD WIDE REVENUE ⁽¹⁾ (Unaudited)

	SECOND QUARTER							YEAR-TO-DATE
	REPORTED				ORGANIC			REPORTED				ORGANIC
(in millions)	FY25	FY24	Growth	Currency Impact ⁽³⁾	Adjusted FY25 ⁽⁴⁾	Adjusted FY24 ⁽⁴⁾	Growth	FY25	FY24	Growth	Currency Impact ⁽³⁾	Adjusted FY25 ⁽⁵⁾	Adjusted FY24 ⁽⁵⁾	Growth
Cardiovascular	$ 3,102	$ 2,923	6.1 %	$ 16	$ 3,086	$ 2,923	5.6 %	$ 6,108	$ 5,773	5.8 %	$ (23)	$ 6,132	$ 5,773	6.2 %
Cardiac Rhythm & Heart Failure	1,578	1,492	5.8	11	1,567	1,492	5.0	3,114	2,938	6.0	(8)	3,122	2,938	6.2
Structural Heart & Aortic	881	819	7.6	4	877	819	7.1	1,736	1,633	6.3	(8)	1,744	1,633	6.8
Coronary & Peripheral Vascular	643	613	4.9	1	642	613	4.8	1,259	1,202	4.7	(7)	1,266	1,202	5.3
Neuroscience	2,451	2,288	7.1	10	2,441	2,288	6.7	4,768	4,506	5.8	(8)	4,776	4,506	6.0
Cranial & Spinal Technologies	1,234	1,157	6.7	3	1,231	1,157	6.4	2,382	2,260	5.4	(6)	2,387	2,260	5.6
Specialty Therapies	737	705	4.6	5	732	705	3.9	1,450	1,400	3.5	(2)	1,452	1,400	3.7
Neuromodulation	480	426	12.6	2	478	426	12.1	937	846	10.8	(1)	938	846	10.9
Medical Surgical	2,128	2,103	1.2	10	2,117	2,103	0.7	4,123	4,107	0.4	(18)	4,142	4,107	0.8
Surgical & Endoscopy	1,649	1,641	0.5	9	1,641	1,641	—	3,193	3,187	0.2	(13)	3,207	3,187	0.6
Acute Care & Monitoring	478	462	3.6	1	477	462	3.3	930	921	1.0	(5)	935	921	1.6
Diabetes	686	610	12.4	9	678	610	11.0	1,333	1,189	12.1	5	1,329	1,189	11.8
Total Reportable Segments	8,366	7,923	5.6	45	8,322	7,923	5.0	16,333	15,575	4.9	(46)	16,379	15,575	5.2
Other ⁽²⁾	37	61	(38.9)	—	—	—	—	(15)	111	(113.5)	(2)	—	—	—
TOTAL	$ 8,403	$ 7,984	5.3 %	$ 45	$ 8,322	$ 7,923	5.0 %	$ 16,318	$ 15,686	4.0 %	$ (48)	$ 16,379	$ 15,575	5.2 %


(1)	The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely.
(2)	Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, and specifically for the three months ended July 26, 2024, impacting year-to-date figures, $90 million of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015.
(3)	The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates.
(4)	The three months ended October 25, 2024 includes $82 million of revenue adjustments related to $37 million of inorganic revenue for the transition activity noted in (2) and $45 million of favorable currency impact on the remaining segments. The three months ended October 27, 2023 excludes $61 million of inorganic revenue related to the transition activity noted in (2).
(5)	The six months ended October 25, 2024 excludes $61 million of revenue adjustments related to $90 million of incremental Italian payback accruals further described in note (2), $75 million of inorganic revenue related to the transition activity noted in (2), and $46 million of unfavorable currency impact on the remaining segments. The six months ended October 27, 2023 excludes $111 million of inorganic revenue related to the transition activity noted in (2).

MEDTRONIC PLC U.S. ⁽¹⁾⁽²⁾ REVENUE (Unaudited)

	SECOND QUARTER						YEAR-TO-DATE
	REPORTED			ORGANIC			REPORTED			ORGANIC
(in millions)	FY25	FY24	Growth	Adjusted FY25	Adjusted FY24	Growth	FY25	FY24	Growth	Adjusted FY25	Adjusted FY24	Growth
Cardiovascular	$ 1,434	$ 1,427	0.5 %	$ 1,434	$ 1,427	0.5 %	$ 2,836	$ 2,776	2.2 %	$ 2,836	$ 2,776	2.2 %
Cardiac Rhythm & Heart Failure	768	782	(1.8)	768	782	(1.8)	1,534	1,502	2.1	1,534	1,502	2.1
Structural Heart & Aortic	388	367	5.7	388	367	5.7	757	724	4.5	757	724	4.5
Coronary & Peripheral Vascular	278	278	0.1	278	278	0.1	546	550	(0.8)	546	550	(0.8)
Neuroscience	1,677	1,560	7.5	1,677	1,560	7.5	3,242	3,057	6.0	3,242	3,057	6.0
Cranial & Spinal Technologies	926	863	7.2	926	863	7.2	1,781	1,685	5.7	1,781	1,685	5.7
Specialty Therapies	418	403	3.6	418	403	3.6	816	795	2.6	816	795	2.6
Neuromodulation	333	293	13.7	333	293	13.7	645	577	11.8	645	577	11.8
Medical Surgical	944	948	(0.4)	944	948	(0.4)	1,825	1,815	0.5	1,825	1,815	0.5
Surgical & Endoscopy	675	688	(1.9)	675	688	(1.9)	1,304	1,308	(0.2)	1,304	1,308	(0.2)
Acute Care & Monitoring	269	260	3.6	269	260	3.6	521	508	2.6	521	508	2.6
Diabetes	232	217	6.9	232	217	6.9	447	405	10.4	447	405	10.4
Total Reportable Segments	4,286	4,151	3.3	4,286	4,151	3.3	8,350	8,054	3.7	8,350	8,054	3.7
Other ⁽³⁾	18	23	(22.2)	—	—	—	37	45	(19.0)	—	—	—
TOTAL	$ 4,304	$ 4,175	3.1 %	$ 4,286	$ 4,151	3.3 %	$ 8,387	$ 8,099	3.6 %	$ 8,350	$ 8,054	3.7 %


(1)	U.S. includes the United States and U.S. territories.
(2)	The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely.
(3)	Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested.

MEDTRONIC PLC INTERNATIONAL REVENUE ⁽¹⁾ (Unaudited)

	SECOND QUARTER							YEAR-TO-DATE
	REPORTED				ORGANIC			REPORTED				ORGANIC
(in millions)	FY25	FY24	Growth	Currency Impact ⁽³⁾	Adjusted FY25 ⁽⁴⁾	Adjusted FY24 ⁽⁴⁾	Growth	FY25	FY24	Growth	Currency Impact ⁽³⁾	Adjusted FY25 ⁽⁵⁾	Adjusted FY24 ⁽⁵⁾	Growth
Cardiovascular	$ 1,668	$ 1,496	11.5 %	$ 16	$ 1,652	$ 1,496	10.4 %	$ 3,272	$ 2,996	9.2 %	$ (23)	$ 3,295	$ 2,996	10.0 %
Cardiac Rhythm & Heart Failure	811	710	14.2	11	799	710	12.6	1,580	1,436	10.0	(8)	1,588	1,436	10.6
Structural Heart & Aortic	492	451	9.1	4	488	451	8.3	980	909	7.8	(8)	988	909	8.7
Coronary & Peripheral Vascular	365	335	8.9	1	364	335	8.7	713	652	9.3	(7)	720	652	10.4
Neuroscience	774	728	6.3	10	764	728	5.0	1,526	1,449	5.3	(8)	1,535	1,449	5.9
Cranial & Spinal Technologies	308	293	5.0	3	305	293	3.9	600	576	4.2	(6)	606	576	5.2
Specialty Therapies	319	302	5.8	5	315	302	4.3	634	605	4.8	(2)	636	605	5.1
Neuromodulation	146	133	10.4	2	144	133	8.8	292	269	8.8	(1)	293	269	9.1
Medical Surgical	1,183	1,155	2.5	10	1,173	1,155	1.6	2,298	2,292	0.3	(18)	2,317	2,292	1.1
Surgical & Endoscopy	974	953	2.3	9	966	953	1.4	1,889	1,879	0.5	(13)	1,902	1,879	1.2
Acute Care & Monitoring	209	202	3.5	1	208	202	2.8	409	413	(0.9)	(5)	414	413	0.4
Diabetes	455	394	15.5	9	446	394	13.2	886	784	13.1	5	882	784	12.5
Total Reportable Segments	4,080	3,772	8.2	45	4,035	3,772	7.0	7,983	7,521	6.1	(46)	8,028	7,521	6.7
Other ⁽²⁾	19	37	(49.4)	—	—	—	—	(51)	66	(178.3)	(2)	—	—	—
TOTAL	$ 4,099	$ 3,809	7.6 %	$ 45	$ 4,035	$ 3,772	7.0 %	$ 7,931	$ 7,587	4.5 %	$ (48)	$ 8,028	$ 7,521	6.7 %

Contacts:
Janet Cho	Ryan Weispfenning
Public Relations	Investor Relations
+1-818-403-7028	+1-763-505-4626

MEDTRONIC PLC CONSOLIDATED STATEMENTS OF INCOME (Unaudited)

	Three months ended		Six months ended
(in millions, except per share data)	October 25, 2024	October 27, 2023	October 25, 2024	October 27, 2023
Net sales	$ 8,403	$ 7,984	$ 16,318	$ 15,686
Costs and expenses:
Cost of products sold, excluding amortization of intangible assets	2,946	2,761	5,707	5,390
Research and development expense	697	698	1,373	1,365
Selling, general, and administrative expense	2,757	2,686	5,412	5,299
Amortization of intangible assets	413	425	827	855
Restructuring charges, net	30	40	77	94
Certain litigation charges, net	—	65	81	105
Other operating income, net	(34)	(31)	(33)	(30)
Operating profit	1,595	1,340	2,873	2,608
Other non-operating income, net	(173)	(154)	(330)	(230)
Interest expense, net	209	180	376	329
Income before income taxes	1,559	1,313	2,827	2,510
Income tax provision	281	402	500	802
Net income	1,278	911	2,327	1,708
Net income attributable to noncontrolling interests	(9)	(2)	(15)	(8)
Net income attributable to Medtronic	$ 1,270	$ 909	$ 2,312	$ 1,700
Basic earnings per share	$ 0.99	$ 0.68	$ 1.79	$ 1.28
Diluted earnings per share	$ 0.99	$ 0.68	$ 1.79	$ 1.28
Basic weighted average shares outstanding	1,282.4	1,330.2	1,288.6	1,330.3

Diluted weighted average shares outstanding	1,286.9	1,331.9	1,292.5	1,332.8

MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS ⁽¹⁾ (Unaudited)

	Three months ended October 25, 2024
(in millions, except per share data)	Net Sales	Cost of Products Sold	Gross Margin Percent	Operating Profit	Operating Profit Percent	Income Before Income Taxes	Net Income attributable to Medtronic	Diluted EPS	Effective Tax Rate
GAAP	$ 8,403	$ 2,946	64.9 %	$ 1,595	19.0 %	$ 1,559	$ 1,270	$ 0.99	18.0 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	413	4.9	413	338	0.26	18.2
Restructuring and associated costs ⁽²⁾	—	(11)	0.1	46	0.5	46	37	0.03	19.6
Acquisition and divestiture-related items ⁽³⁾	—	(5)	0.1	(25)	(0.3)	(25)	(30)	(0.02)	(20.0)
(Gain)/loss on minority investments ⁽⁴⁾	—	—	—	—	—	(10)	(21)	(0.02)	(100.0)
Medical device regulations ⁽⁵⁾	—	(9)	0.1	12	0.1	12	10	0.01	16.7
Certain tax adjustments, net	—	—	—	—	—	—	16	0.01	—
Non-GAAP	$ 8,403	$ 2,921	65.2 %	$ 2,041	24.3 %	$ 1,995	$ 1,620	$ 1.26	18.3 %
Currency impact	(45)	(103)	1.1	145	1.9			0.09
Currency Adjusted	$ 8,358	$ 2,818	66.3 %	$ 2,186	26.2 %			$ 1.35

	Three months ended October 27, 2023
(in millions, except per share data)	Net Sales	Cost of Products Sold	Gross Margin Percent	Operating Profit	Operating Profit Percent	Income Before Income Taxes	Net Income attributable to Medtronic	Diluted EPS	Effective Tax Rate
GAAP	$ 7,984	$ 2,761	65.4 %	$ 1,340	16.8 %	$ 1,313	$ 909	$ 0.68	30.6 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	425	5.3	425	360	0.27	15.3
Restructuring and associated costs ⁽²⁾	—	(15)	0.2	91	1.1	91	76	0.06	17.6
Acquisition and divestiture-related items ⁽³⁾	—	(6)	0.1	58	0.7	58	51	0.04	12.1
Certain litigation charges, net	—	—	—	65	0.8	65	50	0.04	23.1
(Gain)/loss on minority investments ⁽⁴⁾	—	—	—	—	—	25	21	0.02	20.0
Medical device regulations ⁽⁵⁾	—	(21)	0.3	30	0.4	30	24	0.02	20.0
Certain tax adjustments, net ⁽⁶⁾	—	—	—	—	—	—	176	0.13	—
Non-GAAP	$ 7,984	$ 2,720	65.9 %	$ 2,009	25.2 %	$ 2,008	$ 1,667	$ 1.25	16.9 %


See description of non-GAAP financial measures contained in the press release dated November 19, 2024.
(1)	The data in this schedule has been intentionally rounded to the nearest million or $0.01 for EPS figures, and, therefore, may not sum.
(2)	Associated costs primarily include salaries and wages for employees supporting the restructuring activities, consulting expenses, and asset write-offs.
(3)	The charges primarily include business combination costs, changes in fair value of contingent consideration, and exit of business-related charges. The three months ended October 25, 2024, also include gains related to certain business or asset sales.
(4)	We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.
(5)	The charges represent incremental costs of complying with the new European Union (E.U.) medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period.
(6)	The charge primarily relates to the establishment of a valuation allowance against certain net operating losses.

MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS ⁽¹⁾ (Unaudited)

	Six months ended October 25, 2024
(in millions, except per share data)	Net Sales	Cost of Products Sold	Gross Margin Percent	Operating Profit	Operating Profit Percent	Income Before Income Taxes	Net Income attributable to Medtronic	Diluted EPS	Effective Tax Rate
GAAP	$ 16,318	$ 5,707	65.0 %	$ 2,873	17.6 %	$ 2,827	$ 2,312	$ 1.79	17.7 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	827	4.9	827	678	0.52	18.0
Restructuring and associated costs ⁽²⁾	—	(20)	0.1	108	0.6	108	87	0.07	19.4
Acquisition and divestiture-related items ⁽³⁾	—	(16)	0.1	(13)	(0.1)	(13)	(19)	(0.01)	(46.2)
Certain litigation charges, net	—	—	—	81	0.5	81	68	0.05	16.0
(Gain)/loss on minority investments ⁽⁴⁾	—	—	—	—	—	(27)	(38)	(0.03)	(37.0)
Medical device regulations ⁽⁵⁾	—	(20)	0.1	27	0.2	27	22	0.02	18.5
Other ⁽⁶⁾	90	—	0.4	90	0.5	90	70	0.05	22.2
Certain tax adjustments, net	—	—	—	—	—	—	33	0.03	—
Non-GAAP	$ 16,408	$ 5,651	65.6 %	$ 3,993	24.3 %	$ 3,921	$ 3,213	$ 2.49	17.7 %
Currency impact	46	(134)	0.9	246	1.5			0.16
Currency Adjusted	$ 16,454	$ 5,517	66.5 %	$ 4,239	25.8 %			$ 2.65

	Six months ended October 27, 2023
(in millions, except per share data)	Net Sales	Cost of Products Sold	Gross Margin Percent	Operating Profit	Operating Profit Percent	Income Before Income Taxes	Net Income attributable to Medtronic	Diluted EPS	Effective Tax Rate
GAAP	$ 15,686	$ 5,390	65.6 %	$ 2,608	16.6 %	$ 2,510	$ 1,700	$ 1.28	32.0 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	855	5.5	855	724	0.54	15.2
Restructuring and associated costs ⁽²⁾	—	(30)	0.2	182	1.2	182	152	0.11	16.5
Acquisition and divestiture-related items ⁽³⁾	—	(12)	0.1	107	0.7	107	97	0.07	9.3
Certain litigation charges, net	—	—	—	105	0.7	105	81	0.06	22.9
(Gain)/loss on minority investments ⁽⁴⁾	—	—	—	—	—	89	85	0.06	5.6
Medical device regulations ⁽⁵⁾	—	(42)	0.3	62	0.4	62	49	0.04	21.0
Certain tax adjustments, net ⁽⁷⁾	—	—	—	—	—	—	375	0.28	—
Non-GAAP	$ 15,686	$ 5,306	66.2 %	$ 3,919	25.0 %	$ 3,910	$ 3,262	$ 2.45	16.4 %


See description of non-GAAP financial measures contained in the press release dated November 19, 2024.
(1)	The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum.
(2)	Free cash flow represents operating cash flows less property, plant, and equipment additions.

MEDTRONIC PLC CONSOLIDATED BALANCE SHEETS (Unaudited)

(in millions)	October 25, 2024	April 26, 2024
ASSETS
Current assets:
Cash and cash equivalents	$ 1,394	$ 1,284
Investments	6,595	6,721
Accounts receivable, less allowances and credit losses of $195 and $173, respectively	6,260	6,128
Inventories	5,479	5,217
Other current assets	2,710	2,584
Total current assets	22,438	21,935
Property, plant, and equipment, net	6,438	6,131
Goodwill	41,161	40,986
Other intangible assets, net	12,423	13,225
Tax assets	3,572	3,657
Other assets	4,009	4,047
Total assets	$ 90,042	$ 89,981
LIABILITIES AND EQUITY
Current liabilities:
Current debt obligations	$ 3,719	$ 1,092
Accounts payable	2,376	2,410
Accrued compensation	1,893	2,375
Accrued income taxes	947	1,330
Other accrued expenses	3,260	3,582
Total current liabilities	12,195	10,789
Long-term debt	24,607	23,932
Accrued compensation and retirement benefits	1,084	1,101
Accrued income taxes	1,432	1,859
Deferred tax liabilities	473	515
Other liabilities	1,534	1,365
Total liabilities	41,326	39,561
Commitments and contingencies
Shareholders' equity:
Ordinary shares— par value $0.0001, 2.6 billion shares authorized, 1,282,553,150 and 1,311,337,531 shares issued and outstanding, respectively	—	—
Additional paid-in capital	20,824	23,129
Retained earnings	30,919	30,403
Accumulated other comprehensive loss	(3,250)	(3,318)
Total shareholders' equity	48,494	50,214
Noncontrolling interests	222	206
Total equity	48,716	50,420
Total liabilities and equity	$ 90,042	$ 89,981

Contacts:

Erika Winkels	Ryan Weispfenning
Public Relations	Investor Relations
+1-763-526-8478	+1-763-505-4626

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