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Flexima™ APDL M001271390Recalls & reported problems

Boston Scientific Corporation · Drainage Catheter System · Class 2 · Implant

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 08714729323150), received between Dec 17, 2020 and Dec 17, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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

  • Defective Device1

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.

  • MalfunctionDec 17, 2020Defective Device; Defective Device

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED WITH 15DEC2020. IT WAS REPORTED THAT THE DEVICE WAS DAMAGED. A FLEXIMA APDL WAS SELECTED FOR USE AND ATTACHED TO THE PATIENT'S ABDOMEN. DURING PREPARATION, IT WAS NOTED THAT THE DEVICE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WAS A TEAR IN THE PIGTAIL SECTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 11028011 ↗

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.