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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Condensed Consolidated Statements of Income (unaudited)
	Three months ended
	March 30,			% of		April 1,			% of
(Dollars in millions except per share amounts)	2024			Revenues		2023			Revenues
Revenues	$	10,345				$	10,710
Costs and operating expenses:
Cost of revenues (a)		6,040		58.4	%		6,437		60.1	%
Selling, general and administrative expenses (b)		1,731		16.7	%		1,646		15.4	%
Amortization of acquisition-related intangible assets		551		5.3	%		606		5.7	%
Research and development expenses		331		3.2	%		346		3.2	%
Restructuring and other costs (c)		29		0.3	%		112		1.0	%
Total costs and operating expenses		8,682		83.9	%		9,147		85.4	%
Operating income		1,663		16.1	%		1,563		14.6	%
Interest income		279					146
Interest expense		(363	)				(300	)
Other income/(expense) (d)		10					(46	)
Income before income taxes		1,589					1,363
Provision for income taxes (e)		(281	)				(46	)
Equity in earnings/(losses) of unconsolidated entities		23					(25	)
Net income		1,331					1,292
Less: net income/(losses) attributable to noncontrolling interests and redeemable noncontrolling interest		4					3
Net income attributable to Thermo Fisher Scientific Inc.	$	1,328		12.8	%	$	1,289		12.0	%

Earnings per share attributable to Thermo Fisher Scientific Inc.:
Basic	$	3.47				$	3.34
Diluted	$	3.46				$	3.32
Weighted average shares:
Basic		382					386
Diluted		384					388

Reconciliation of adjusted operating income and adjusted operating margin
GAAP operating income	$	1,663		16.1	%	$	1,563		14.6	%
Cost of revenues adjustments (a)		15		0.1	%		41		0.4	%
Selling, general and administrative expenses adjustments (b)		19		0.2	%		8		0.1	%
Restructuring and other costs (c)		29		0.3	%		112		1.0	%
Amortization of acquisition-related intangible assets		551		5.3	%		606		5.7	%
Adjusted operating income (non-GAAP measure)	$	2,278		22.0	%	$	2,330		21.8	%

Reconciliation of adjusted net income
GAAP net income attributable to Thermo Fisher Scientific Inc.	$	1,328				$	1,289
Cost of revenues adjustments (a)		15					41
Selling, general and administrative expenses adjustments (b)		19					8
Restructuring and other costs (c)		29					112
Amortization of acquisition-related intangible assets		551					606
Other income/expense adjustments (d)		(11	)				46
Provision for income taxes adjustments (e)		50					(171	)
Equity in earnings/losses of unconsolidated entities		(23	)				25
Adjusted net income (non-GAAP measure)	$	1,959				$	1,956

Reconciliation of adjusted earnings per share
GAAP diluted EPS attributable to Thermo Fisher Scientific Inc.	$	3.46				$	3.32
Cost of revenues adjustments (a)		0.04					0.10
Selling, general and administrative expenses adjustments (b)		0.05					0.02
Restructuring and other costs (c)		0.08					0.29
Amortization of acquisition-related intangible assets		1.44					1.56
Other income/expense adjustments (d)		(0.03	)				0.12
Provision for income taxes adjustments (e)		0.13					(0.44	)
Equity in earnings/losses of unconsolidated entities		(0.06	)				0.06
Adjusted EPS (non-GAAP measure)	$	5.11				$	5.03

Reconciliation of free cash flow
GAAP net cash provided by operating activities	$	1,251				$	729
Purchases of property, plant and equipment		(347	)				(458	)
Proceeds from sale of property, plant and equipment		4					6
Free cash flow (non-GAAP measure)	$	908				$	277

Business Segment Information	Three months ended
	March 30,			% of		April 1,			% of
(Dollars in millions)	2024			Revenues		2023			Revenues

Revenues
Life Sciences Solutions	$	2,285		22.1	%	$	2,612		24.4	%
Analytical Instruments		1,687		16.3	%		1,723		16.1	%
Specialty Diagnostics		1,109		10.7	%		1,108		10.3	%
Laboratory Products and Biopharma Services		5,723		55.3	%		5,763		53.8	%
Eliminations		(460	)	-4.4	%		(496	)	-4.6	%
Consolidated revenues	$	10,345		100.0	%	$	10,710		100.0	%

Segment income and segment income margin
Life Sciences Solutions	$	840		36.8	%	$	836		32.0	%
Analytical Instruments		400		23.7	%		421		24.4	%
Specialty Diagnostics		294		26.5	%		280		25.3	%
Laboratory Products and Biopharma Services		744		13.0	%		793		13.8	%
Subtotal reportable segments		2,278		22.0	%		2,330		21.8	%
Cost of revenues adjustments (a)		(15	)	-0.1	%		(41	)	-0.4	%
Selling, general and administrative expenses adjustments (b)		(19	)	-0.2	%		(8	)	-0.1	%
Restructuring and other costs (c)		(29	)	-0.3	%		(112	)	-1.0	%
Amortization of acquisition-related intangible assets		(551	)	-5.3	%		(606	)	-5.7	%
Consolidated GAAP operating income	$	1,663		16.1	%	$	1,563		14.6	%


(a) Adjusted results in 2024 and 2023 exclude charges for inventory write-downs associated with large-scale abandonment of product lines. Adjusted results in 2023 exclude $10 of charges for the sale of inventory revalued at the date of acquisition.
(b) Adjusted results in 2024 and 2023 exclude certain third-party expenses, principally transaction/integration costs related to recent acquisitions, and charges/credits for changes in estimates of contingent acquisition consideration.
(c) Adjusted results in 2024 and 2023 exclude restructuring and other costs consisting principally of severance, impairments of long-lived assets, abandoned facility, and other expenses of headcount reductions and real estate consolidations. Adjusted results in 2023 also exclude $18 of net charges for pre-acquisition litigation and other matters.
(d) Adjusted results in 2024 and 2023 exclude net gains/losses on investments.
(e) Adjusted results in 2024 and 2023 exclude incremental tax impacts for the reconciling items between GAAP and adjusted net income, incremental tax impacts as a result of tax rate/law changes, and the tax impacts from audit settlements.
Note:
Consolidated depreciation expense is $285 and $253 in 2024 and 2023, respectively.

Organic and Core organic revenue growth		Three months ended
		March 30, 2024
Revenue growth		-3%
Acquisitions		0%
Currency translation		0%
Organic revenue growth (non-GAAP measure)		-4%
COVID-19 testing revenue		-1%
Core organic revenue growth (non-GAAP measure)		-3%

Note:
For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release.

Condensed Consolidated Balance Sheets (unaudited)

	March 30,		December 31,
(In millions)	2024		2023

Assets
Current assets:
Cash and cash equivalents	$	5,499	$	8,077
Short-term investments		1,751		3
Accounts receivable, net		7,931		8,221
Inventories		5,133		5,088
Other current assets		3,326		3,200
Total current assets		23,640		24,589
Property, plant and equipment, net		9,324		9,448
Acquisition-related intangible assets, net		16,048		16,670
Other assets		4,241		3,999
Goodwill		43,843		44,020
Total assets	$	97,095	$	98,726

Liabilities, redeemable noncontrolling interest and equity
Current liabilities:
Short-term obligations and current maturities of long-term obligations	$	4,451	$	3,609
Other current liabilities		9,486		10,403
Total current liabilities		13,937		14,012
Other long-term liabilities		6,378		6,564
Long-term obligations		31,157		31,308
Redeemable noncontrolling interest		119		118
Total equity		45,504		46,724
Total liabilities, redeemable noncontrolling interest and equity	$	97,095	$	98,726

Condensed Consolidated Statements of Cash Flows (unaudited)

	Three months ended
	March 30,			April 1,
(In millions)	2024			2023

Operating activities
Net income	$	1,331		$	1,292
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization		837			859
Change in deferred income taxes		(253	)		(146	)
Other non-cash expenses, net		123			257
Changes in assets and liabilities, excluding the effects of acquisitions		(787	)		(1,533	)
Net cash provided by operating activities		1,251			729

Investing activities
Purchases of property, plant and equipment		(347	)		(458	)
Proceeds from sale of property, plant and equipment		4			6
Proceeds from cross-currency interest rate swap interest settlements		64			2
Acquisitions, net of cash acquired		—			(2,704	)
Purchases of investments		(1,758	)		(2	)
Other investing activities, net		7			14
Net cash used in investing activities		(2,030	)		(3,142	)

Financing activities
Net proceeds from issuance of debt		1,205			—
Net proceeds from issuance of commercial paper		—			1,027
Repayment of commercial paper		—			(523	)
Purchases of company common stock		(3,000	)		(3,000	)
Dividends paid		(135	)		(117	)
Other financing activities, net		110			20
Net cash used in financing activities		(1,821	)		(2,593	)

Exchange rate effect on cash		22			(31	)
Decrease in cash, cash equivalents and restricted cash		(2,578	)		(5,037	)
Cash, cash equivalents and restricted cash at beginning of period		8,097			8,537
Cash, cash equivalents and restricted cash at end of period	$	5,519		$	3,500

Free cash flow (non-GAAP measure)	$	908		$	277



Note:
For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release.

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

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