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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 7 of 7 Results
PMA Number: P140003
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Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with... 2 02/22/2024 Abiomed, Inc.
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory syste... 1 02/09/2024 Abiomed, Inc.
Impella Connect, software portal for online device management that allows clinicians and Impella sup... 2 01/04/2024 Abiomed, Inc.
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.... 2 12/01/2023 Abiomed, Inc.
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.... 2 12/01/2023 Abiomed, Inc.
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a pat... 1 05/18/2023 Abiomed, Inc.
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use Duri... 2 11/07/2019 Abiomed, Inc.
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