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Flexima™ APDL M001281380Recalls & reported problems

Boston Scientific Corporation · Drainage Catheter System with Dissolving Tip · 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 08714729127970), received between Oct 25, 2018 and Oct 25, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1

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.

  • MalfunctionOct 25, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED VIA FACILITY MEDWATCH MW5079751, THAT THE TIP BROKE OFF. A 12/25 FLEXIMA APDL WAS SELECTED FOR A CT GUIDED DRAINAGE OF INTRA-ABDOMINAL ABSCESS WITH CATHETER REPLACEMENT. DURING PROCEDURE, THE RADIOLOGIST DILATED THE TRACT AND WHEN TRYING TO PLACE THE CATHETER HE ENCOUNTERED RESISTANCE. UPON TRYING TO REMOVE THE CATHETER, THE TIP BROKE OFF INTO TWO PIECES. THE RADIOLOGIST WAS ABLE TO RETRIEVE ALL COMPONENTS OF THE DEVICE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8005414 ↗

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.