Percuflex™ Plus M006175262010Recalls & reported problems
Boston Scientific Corporation · Ureteral Stent Set · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729340003), received between Aug 17, 2017 and Aug 17, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2017Difficult to Remove; Difficult to Remove
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX¿ PLUS URETERAL STENT WAS IMPLANTED IN THE URETER ON (B)(6) 2017, AND WAS ATTEMPTED TO BE REMOVED DURING A REMOVAL CATHETER J PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE REMOVAL CATHETER J PROCEDURE, AN ATTEMPT TO REMOVE THE PERCUFLEX¿ PLUS URETERAL STENT WAS PERFORMED; HOWEVER, DISTAL DOUBLE J FAILED TO UNCOIL LEAVING THE STENT STUCK IN THE DISTAL END OF THE URETER. THE STENT WAS CUT USING A HOLMIUM LASER AND THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA TO UNDERGO A TWO HOUR SURGERY. ADDITIONALLY, IT WAS REPORTED THAT TRAUMA WAS NOTED ON THE URETER INCREASING THE SURGICAL RISK AND THE POSSIBLE COMPLICATIONS. DURING THE SURGERY THE PATIENT HAD TRAUMA IN THE URETER DUE TO HANDLING, BUT THE PATIENT IS STABLE NOW, WITHOUT INJURY, AT THE CONCLUSION OF THE PROCEDURE.
Patient problems: No Code Available
MAUDE report 6801279 ↗
Other STENT, URETERAL devices
- Bard® InLay Optima® Ureteral Stent 788426C. R. Bard, Inc. · STENT, URETERAL1 recall100 reports
- Bard® InLay Optima® Ureteral Stent 788626C. R. Bard, Inc. · STENT, URETERAL122 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777626C. R. Bard, Inc. · STENT, URETERAL118 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777426C. R. Bard, Inc. · STENT, URETERAL108 reports
- Bard® InLay® Ureteral Stent 778626C. R. Bard, Inc. · STENT, URETERAL100 reports
- Percuflex™ Plus M0061752530Boston Scientific Corporation · STENT, URETERAL1 death99 reports
- Contour VL™ M0061801560Boston Scientific Corporation · STENT, URETERAL1 recall45 reports
- Polaris™ Ultra M0061921330Boston Scientific Corporation · STENT, URETERAL71 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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