Percuflex™ Plus M006175262080Recalls & reported problems
Boston Scientific Corporation · Ureteral Stent Set · Class 2 · Implant
All models of Percuflex Plus (35)
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 08714729297406), received between Mar 8, 2019 and Mar 8, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Difficult to Remove1
- Material Deformation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 8, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS STENT WAS IMPLANTED AFTER A TUL PROCEDURE THAT TOOK PLACE IN FEBRUARY OF 2019. IT WAS IMPLANTED FOR A DURATION OF ABOUT TWO WEEKS. THE EXACT IMPLANT DATE WAS NOT PROVIDED. ACCORDING TO THE COMPLAINANT, DURING SCHEDULED REMOVAL IN THE FLUOROSCOPY ROOM, THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT, BUT IT WAS NOTICED THAT THE COIL OF THE STENT WAS BENT AND WAS STUCK AT THE U3 AREA POSITION IN THE PATIENTS URETER. THERE WAS DIFFICULTY IN REMOVING THE STENT. THE PROCEDURE WAS CANCELLED, THE PATIENT WAS DISCHARGED TO GO HOME, AND THE PROCEDURE WAS RESCHEDULED FOR ON (B)(6) 2019 FOR REMOVAL OF THE STENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8404865 ↗
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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