Percuflex™ Urinary Diversion Stent Set M0061602150Recalls & reported problems
Boston Scientific Corporation · Urinary Diversion Stent Set · Class U · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729297185), received between Feb 10, 2017 and Jun 23, 2025 — classified as 3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2025Break; Break
IT WAS REPORTED THAT A PERCUFLEX URINARY DIVERSION STENT WAS IMPLANTED INTO THE PATIENT. POST PROCEDURE, IT WAS NOTED THAT THE STENT WAS FRAGMENTED INTO PIECES WHILE IT WAS BEING REMOVED. THERE WAS NO INFORMATION IF A NEW STENT WAS IMPLANTED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22312352 ↗MalfunctionAug 31, 2023Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN PERCUFLEX URINARY DIVERSION STENT SET WAS RECEIVED ON AUGUST 07, 2023. IT WAS FOUND THAT THE STENT ARRIVED IN THE FACILITY DAMAGED. IT WAS OBSERVED THAT THE PACKAGING WAS SOMEHOW AFFECTED BY HEAT. THE STERILE BARRIER WAS COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT, AND THIS DEVICE WAS NOT USED IN A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17660668 ↗MalfunctionFeb 10, 2017Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX¿ URINARY DIVERSION STENT SET WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE STENT'S PIGTAIL DETACHED AS THE SURGEON WENT TO THREAD IT OVER THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PERCUFLEX¿ URINARY DIVERSION STENT SET. 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 FINE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6321220 ↗
Other CATHETER, NEPHROSTOMY devices
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- Dawson Mueller G09705Cook Incorporated · CATHETER, NEPHROSTOMY2 deaths215 reports
- Cook G09497Cook Incorporated · CATHETER, NEPHROSTOMY129 reports
- Dawson Mueller G11020Cook Incorporated · CATHETER, NEPHROSTOMY100 reports
- Cook G09502Cook Incorporated · CATHETER, NEPHROSTOMY86 reports
- NephroMax Kit M0062101180Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall25 reports
- NephroMax Kit M0062101600Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall11 reports
- Dawson Mueller G13768Cook Incorporated · CATHETER, NEPHROSTOMY59 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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