Getinge USA Inc.
1777 E. Henrietta Road
Rochester , NY 14623
USA
Phone: 800-475-9040
Fax: 585-272-5033
[email protected]
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The US Food and Drug Administration is alerting health care providers and facilities about our continued safety and quality concerns with the following Getinge/Maquet cardiovascular medical devices
News | FDA
FDA Notes Safety and Quality Concerns with Getinge/Maquet Cardiovascular Devices

May 8, 2024 — The US Food and Drug Administration (FDA) is alerting health care providers and facilities about our ...

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Getinge and Cook Medical announced an exclusive sales and distribution agreement for the iCast covered stent system, which has been on the market for twenty years and recently received premarket approval for treatment of iliac arterial occlusive disease
News | Stents
Getinge Enters into Commercial Distribution Agreement with Cook Medical for iCast Covered Stent System in the United States

April 17, 2024 — Getinge and Cook Medical announced an exclusive sales and distribution agreement for the iCast covered ...

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An unprecedented collaboration between an eminent heart surgeon, a Michelin-starred chef and a global cardiovascular device provider sees the launch of a unique, surgically inspired recipe book, conceived to help surgeons practice their surgical dexterity in an unexpected way
News | Cardiovascular Business
A World-first Collaboration to Help Heart Surgeons Utilize Their Dexterity in an Unexpected Way – Introducing The Heart Surgeon’s Cookbook

January 12, 2024 — The Heart Surgeon’s Cookbook is the brainchild of New York-based Cardiovascular and Thoracic Surgeon ...

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Getinge announced commercial availability of the iCast covered stent system in the United States
News | Peripheral Artery Disease (PAD)
Getinge Announces U.S. Commercial Availability of iCast Covered Stent System for Treatment of Iliac Arterial Occlusive Disease

November 10, 2023 —Getinge announced commercial availability of the iCast covered stent system in the United States for ...

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The FDA has announced that Datascope/Maquet/Getinge is recalling the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) because they may shutdown unexpectedly due to electrical failures in the Power Management Board and/or Solenoid Board (Power Source Path).
News | Intra-Aortic Balloon Pumps (IABP)
Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Unexpected Shutdowns

August 14, 2023 — The FDA has announced that Datascope/Maquet/Getinge is recalling the Cardiosave Hybrid and Rescue ...

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Datascope Recalls Intra-Aortic Balloon Pumps Due to Potential Battery Failure. FDA Class I recall includes the Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i IABP.
Feature | Intra-Aortic Balloon Pumps (IABP)
Datascope Recalls Intra-Aortic Balloon Pumps Due to Potential Battery Failure

July 24, 2019 — The U.S. Food and Drug Administration announced Maquet/Datascope is recalling all intra-aortic balloon ...

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he U.S. Food and Drug Administration (FDA) is evaluating recent reports of Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices shutting down while running on battery power.
News | Intra-Aortic Balloon Pumps (IABP)
Maquet/Datascope Intra-Aortic Balloon Pumps Might Fail on Battery Power

November 5, 2018 — The U.S. Food and Drug Administration (FDA) is evaluating recent reports of Getinge's Maquet ...

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Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump
News | Intra-Aortic Balloon Pumps (IABP)
Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump

September 24, 2018 — Getinge is voluntarily initiating a worldwide recall involving a field correction of approximately ...

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