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FDA Scolds Abiomed for Not Seeking a PMA for Its Web-Based User Portal

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FDA Scolds Abiomed for Not Seeking a PMA for Its Web-Based User Portal

October 17, 2023

Label for Impella RP Flex Catheters Recalled to Address Anticoagulant Confusion: FDA

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Label for Impella RP Flex Catheters Recalled to Address Anticoagulant Confusion: FDA

August 18, 2023

Cardiosave IABPs Recalled Again, This Time Due to Potential Electrical Problems: FDA

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Cardiosave IABPs Recalled Again, This Time Due to Potential Electrical Problems: FDA

Michael O'Riordan

August 10, 2023

Abiomed Recalls Certain Impella 5.5 Devices Due to Risk of Purge-Fluid Leaks

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Abiomed Recalls Certain Impella 5.5 Devices Due to Risk of Purge-Fluid Leaks

June 05, 2023

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

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Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

March 31, 2023

New IABP Recall: Balloon Catheter Damage Might Cause Bleeding Into Pump

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New IABP Recall: Balloon Catheter Damage Might Cause Bleeding Into Pump

January 25, 2023

Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

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Medical Devices Cleared on Faulty Predicates More Likely to be Recalled

Michael O'Riordan

January 17, 2023

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