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Flexima™ APDL M001271320Recalls & reported problems

Boston Scientific Corporation · Drainage Catheter System · 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 08714729191759), received between Nov 29, 2022 and Nov 29, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionNov 29, 2022Break; Break

    IT WAS REPORTED THAT THE STRING IS ABOUT TO RIP OR HAS PULLED AWAY. AN 8 FLEXIMA APDL DRAINAGE CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT APPEARS THAT THE STRING IS ABOUT TO RIP OR HAS PULLED AWAY AT THE LOOP WHERE THE STRING IS. CONSEQUENTLY, THEY DID NOT USE THIS PARTICULAR CATHETER ON THE PATIENT. THEY USED ANOTHER ONE, WITH THE SAME BATCH NUMBER WHICH APPEARED TO BE FINE AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15880172 ↗

Other TUBE, DRAINAGE, SUPRAPUBIC devices

All TUBE, DRAINAGE, SUPRAPUBIC devices →

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