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LI Plus 417670Recalls & reported problems

Greatbatch Ltd · Biotronik LI Plus PTFE Introducer Kit · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821329400360), received between Mar 6, 2020 and Mar 6, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Delivered as Unsterile Product1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 6, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

    A HAIR WAS FOUND WHEN THE DEVICE PACKAGE WAS OPENED. THE DEVICE WAS NOT USED. THERE WAS NO ADVERSE PATIENT IMPACT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9799498 ↗

Other Introducer, Catheter devices

All Introducer, Catheter devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.