Percuflex™ Plus M0061752650Recalls & reported problems
Boston Scientific Corporation · Ureteral Stent · Class 2 · Implant
Data updated Oct 13, 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 08714729067849), received between May 20, 2022 and May 20, 2022 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS TO REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TWO PREVIOUSLY IMPLANTED PERCUFLEX PLUS URETERAL STENT WAS REMOVED FROM THE LEFT AND RIGHT URETER, PERFORMED ON (B)(6) 2022 AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. ON (B)(6) 2022, THE PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY PLACED FOR STONE MANAGEMENT IN THE LEFT AND RIGHT URETER, AND THE PATIENT WAS PRESCRIBED THE DISCHARGE MEDICATIONS ACETAMINOPHEN (TYLENOL) AND NARCOTIC ANALGESICS (OPIOIDS). NO ISSUES WERE NOTED WITH THE DEVICE. ON (B)(6) 2022, THE PATIENT HAD EXPERIENCED A LEFT AND RIGHT FLANK PAIN. THE PATIENT WAS GIVEN TYLENOL, IBUPROFEN, URINE SAMPLE, AND FLOMAX TO TREAT THE PAIN. DURING THE PLANNED STENT REMOVAL PERFORMED ON (B)(6) 2022, THE PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT ANY DIFFICULTY. THERE WERE NO NEW DEVICE IMPLANTED. ON (B)(6) 2022 THE EVENT WAS CONSIDERED RESOLVED.
Patient problems: Pain
MAUDE report 14458482 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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