FDA recall notice

Early Alert: Catheter Introducer Kit Issue from Abiomed

FDA Early Alert - FDA collecting information · Catheter Introducer Kit · posted Jun 2, 2026

Key facts

Notice Early Alert: Catheter Introducer Kit Issue from Abiomed
Device type Catheter Introducer Kit
Status Early Alert - FDA collecting information
Posted Jun 2, 2026
Notice on fda.gov fda.gov

At a glance

  • Early alert Recall confirmed
  • No Currently listed by the FDA
  • None 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:

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