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Percuflex™ Plus M0061752810Recalls & 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 08714729067924), received between Dec 4, 2018 and Dec 4, 2018 — 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 4, 2018Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED TO BE USED FOR A URETEROSCOPY PROCEDURE TO BE PERFORMED IN THE URETER ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE STENT BROKE IN HALF ALONG THE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PERCUFLEX PLUS STENT. THERE WAS NO SERIOUS INJURY NOR WERE THERE ANY ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8131230 ↗

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.