Percuflex™ M001245640Recalls & reported problems
Boston Scientific Corporation · Ureteral Stent System Kit · Class 2
All models of Percuflex (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729032113), received between Jul 6, 2023 and Jan 10, 2024 — classified as 2 malfunctions.
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
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2024Break; Break
IT WAS REPORTED THAT SUTURE DETACHMENT OCCURRED. A PERCUFLEX WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE SUTURE WAS DETACHED IN THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18490400 ↗MalfunctionJul 6, 2023Break; Break
IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. A PERCUFLEX URETERAL STENTS WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE PHYSICIAN PULLED THE STRING TO CREATE LOOP, THE STRING PULLED RIGHT OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PERCUFLEX URETERAL STENTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE. THE DEVICE WAS RETURNED, AND ANALYSIS COMPLETED ON 01AUG2023. THE STENT RETURNED WITH THE FLEXIBLE CANNULA AND THE INTRODUCER FOR ANALYSIS. IT WAS OBSERVED THAT THE SUTURE WAS DETACHED FROM THE STENT. THE POUCH WAS RETURNED, AND IT WAS OBSERVED THAT THE POUCH INFORMATION MATCHES WITH THE COMPLAINT INFORMATION. NO OTHER ISSUES WERE OBSERVED IN THE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17269530 ↗
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