Recalls from Abiomed, Inc.

• Abiomed Impella Controllers (opens in a new tab)
  Moderate risk, FDA, Sep 21, 2026, Software defect
• Abiomed Impella Controllers (opens in a new tab)
  High risk, FDA, Sep 16, 2026, Device defect
• Abiomed Impella Heart Pumps and Introducer Kits (opens in a new tab)
  High risk, FDA, Jul 10, 2026, Manufacturing problem
• Abiomed Impella CP Sets and Low Profile Introducer Kits (opens in a new tab)
  High risk, FDA, Jun 25, 2026, Device defect
• Impella CP Set with SmartAssist (opens in a new tab)
  High risk, FDA, Jun 18, 2026, Device defect

Data: Recall Canary (opens in a new tab)