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device recall
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Abiomed, Inc. device recall (Cls I)

January 27, 2026updated 5mo ago
community read0 votes

Impella RP with SmartAssist. Product Code: 0046-0035. — Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. — Status: Ongoing

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same company · ±60 days · 6

  • device recallAbiomed, Inc. device recall (Cls I)Jan 27, 2026
  • device recallAbiomed, Inc. device recall (Cls I)Jan 27, 2026
  • device pmaAbiomed, Inc. — Impella 2.5 System; Impella CP System; Impella CP with Smart Assist System; Impella 5.0 System, Impella 5.5 with Smart A (PMA supplement)Feb 6, 2026
  • device pmaAbiomed, Inc. — Impella RP System, Impella RP with Smart Assist System, Impella RP Flex System (PMA supplement)Feb 6, 2026
  • device recallAbiomed, Inc. device recall (Cls I)Feb 16, 2026
  • device recallAbiomed, Inc. device recall (Cls I)Feb 18, 2026

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