Percuflex™ M001245520Recalls & reported problems
Boston Scientific Corporation · Ureteral Stent System · Class 2
All models of Percuflex (18)
Data updated Oct 16, 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 08714729170556), received between Aug 25, 2021 and Aug 25, 2021 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
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.
InjuryAug 25, 2021Break; Break
IT WAS REPORTED VIA MEDWATCH (B)(4) THAT THE PIGTAIL CATHETER TIP BROKE AND WAS SNARED TO REMOVE. A PERCUFLEX GUIDE CATHETER WAS SELECTED FOR USE IN URETERAL STENT PLACEMENT (STENT FROM KIDNEY TO BLADDER). DURING THE PROCEDURE, UPON PLACING A BOSTON SCIENTIFIC RIGHT URETERAL STENT SYSTEM, IT WAS NOTED THAT THE PIGTAIL TIP LOCATED IN THE KIDNEY BROKE. THE PHYSICIAN WAS ABLE TO SNARE THE BROKEN LOOP AND THE PROCEDURE WAS COMPLETED AFTER SNARING THE BROKEN PIECE OF THE PIGTAIL CATHETER. IMAGING WAS REVIEWED INDICATING THAT THE URETERAL STENT WAS FUNCTIONING APPROPRIATELY AT THE END OF THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12366128 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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