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Percuflex™ Plus M006175262110Recalls & reported problems

Boston Scientific Corporation · Ureteral Stent Set · 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 08714729297413), received between Mar 19, 2018 and Mar 19, 2018 — classified as 1 malfunction.

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

  • Bent1
  • Difficult to Remove1

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.

  • MalfunctionMar 19, 2018Bent; Difficult to Remove; Bent; Difficult to Remove

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX¿ PLUS STENT WAS REMOVED DURING A STENT REPLACEMENT PROCEDURE PERFORMED IN THE URETER. THE DATE OF THE PROCEDURE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, THERE WAS DIFFICULTY IN REMOVING THE STENT. DURING PROCEDURE, IT WAS NOTICED THAT THE RENAL SIDE TAIL OF THE STENT WOULD NOT BECOME STRAIGHT WHEN THE GUIDEWIRE WAS INSERTED INTO IT. THE GUIDEWIRE CAME OUT FROM THE SIDE HOLE OF THE STENT TAIL. THE STENT WAS REMOVED SUCCESSFULLY WITH THE GUIDEWIRE AFTER SEVERAL ATTEMPTS. A NEW STENT WAS THEN IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7349546 ↗

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.