Skip to content

Flexima™ APD™ M001271370Recalls & 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 08714729323136), received between Dec 22, 2020 and Dec 22, 2020 — classified as 1 malfunction.

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

  • Contamination1
  • Unsealed Device Packaging1

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 22, 2020Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

    IT WAS REPORTED THAT THE PACKAGING BROKE AND THE DEVICE WAS UNSTERILE. A FLEXIMA APDL WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE PACKAGING WAS BROKE THROUGH SO THE DEVICE BECAME UNSTERILE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 11056946 ↗

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.