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Flexcath® Advance 4FC12Recalls & reported problems

Medtronic, Inc. · SHEATH 4FC12 FLEXCATH ADVANCE 12F US · 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 00643169504707), received between Feb 2, 2017 and Feb 2, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Air Leak” (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

  • Air Leak1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionFeb 2, 2017Air Leak; Air Leak

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, WHILE ASPIRATING THE SHEATH AFTER BALLOON WAS INSERTED, ONLY AIR WAS BEING PULLED BACK. THIS OCCURRED WITH THREE SHEATHS WHICH WERE ALL REPLACED IN ADDITION TO THE BALLOON CATHETER. THE PROCEDURE WAS CONTINUED AND COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6296420 ↗

Other CATHETER, STEERABLE devices

All CATHETER, STEERABLE devices →

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