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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

FDA: Class I Recall for Left-Sided Impella Pumps Due to TAVI Interaction

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FDA: Class I Recall for Left-Sided Impella Pumps Due to TAVI Interaction

July 27, 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

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