Percuflex™ M001245530Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729048633), received between Oct 26, 2023 and Aug 15, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2024Break; Break
IT WAS REPORTED THAT THE MARKER WAS DETACHED. A PERCUFLEX DRAINAGE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE MARKER WAS FOUND DETACHED, AND IT TOOK A LONG TIME TO REMOVE THE DEVICE FROM THE PATIENT. THE PHYSICIAN USED ANOTHER DEVICE TO REMOVE THE CATHETER. NO COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19991587 ↗InjuryNov 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE DEVICE GOT DISLODGED INSIDE THE PATIENT. A BALLOON DILATATION CATHETER KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE URETERAL STENT RADIO-OPAQUE BAND, AT DISTAL END BECAME DISLODGED INSIDE THE PATIENT. THEY TRIED TO SNARE RO BAND BUT WAS UNSUCCESSFUL. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 18147667 ↗InjuryOct 26, 2023Break; Break
IT WAS REPORTED THAT A CATHETER BREAK OCCURRED. A PERCUFLEX URETERAL DRAINAGE CATHETER WAS SELECTED FOR USE AND SUCCESSFULLY IMPLANTED. IT WAS NOTED THAT WHILE THE DRAINAGE CATHETER WAS IMPLANTED, THE CATHETER HAD FRACTURED. WHILE REMOVING THE DRAINAGE CATHETER THE FRACTURED PORTION REMAINED INSIDE THE PATIENT. ADDITIONAL INTERVENTION USING A PLIERS WAS PERFORMED TO RETRIEVE THE DEVICE FRAGMENT. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18012420 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page