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Percuflex™ M0061453720Recalls & reported problems

Boston Scientific Corporation · Ureteral Stent · 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 08714729040392), received between Dec 17, 2019 and Dec 17, 2019 — 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 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, 2019Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A PERCUFLEX URETERAL STENT WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS UNPACKED THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PERCUFLEX URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9481645 ↗

Other STENT, URETERAL devices

All STENT, URETERAL devices →

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