Percuflex™ Plus M006175250050Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729339946), received between Oct 8, 2020 and Oct 8, 2020 — classified as 1 malfunction.
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
- Migration1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2020Difficult to Remove; Migration; Difficult to Remove; Migration
IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A STENT IMPLANTATION PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2020 THE DOCTOR ASSESSED THAT THE LENGTH OF THE STENT WAS NOT THE ONE INDICATED TO BE USED FOR THIS PATIENT. THE PHYSICIAN CHOSE TO IMPLANT THE URETERAL STENT AND LEFT THE EXCESS LENGTH IN THE KIDNEY. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2020 IT WAS NOTICED THAT THE IMPLANTED STENT MIGRATED FROM ITS ORIGINAL POSITION TO THE LOW URETER. THE STENT WAS ATTEMPTED TO BE REMOVED VIA CYSTOSCOPE, BUT COULD NOT BE REMOVED. THE REMOVAL PROCEDURE WAS RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10652109 ↗
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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