FDA recall notice

Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist

FDA Recall Confirmed · Heart Pump · posted Jul 2, 2026

Key facts

Notice Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist
Device type Heart Pump
Status Recall Confirmed
Posted Jul 2, 2026
Notice on fda.gov fda.gov

At a glance

  • Confirmed Recall confirmed
  • Yes Currently listed by the FDA
  • 1–9 Recall events referenced
  • 1–9 UDI device identifiers named

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recall notices and early alerts

The FDA's Medical Device Recalls and Early Alerts list covers the most serious device recalls, plus early alerts about potentially high-risk device issues while the FDA is still collecting information. A notice is updated as the recall is confirmed or changes.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls and Early Alerts · Source date:

Browse all FDA device recall notices and early alerts