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Flexima™ M001272630Recalls & reported problems

Boston Scientific Corporation · Biliary Catheter System with Radiopaque Marker · Class 2 · Implant

All models of Flexima (20)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 08714729454984), received between Jun 5, 2023 and Jun 5, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Unsealed Device Packaging1

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.

  • MalfunctionJun 5, 2023Unsealed Device Packaging; Unsealed Device Packaging

    IT WAS REPORTED THAT THE DEVICE WAS CONTAMINATED. A FLEXIMA DRAINAGE CATHETER WAS SELECTED FOR USE. DURING PREPARATION, A TEAR IN THE PACKAGE WAS NOTED, AND STERILITY OF THE DEVICE WAS COMPROMISED. AS PER LAB MANAGER, THE DAMAGE MUST HAVE BEEN DUE TO SHIPPING. AS IT WAS DAMAGED UPON ARRIVAL. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17063344 ↗

Other CATHETER, BILIARY, DIAGNOSTIC devices

All CATHETER, BILIARY, DIAGNOSTIC devices →

Sources and updates

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