Universa G49934Recalls & reported problems
Cook Incorporated · Universa Soft Ureteral Stent Set with Hydrophilic Coating · Class 2 · Implant
All models of Universa (82)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002499348), received between Apr 12, 2018 and Oct 8, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Crack2
- Material Split, Cut or Torn2
- Dent in Material1
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2024Break; Break
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20397734 ↗MalfunctionMay 10, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, A UNIVERSA SOFT URETERAL STENT SET WAS FOUND TO BE FRACTURED. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19285202 ↗MalfunctionApr 15, 2020Crack; Crack
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9961997 ↗MalfunctionJun 10, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8682597 ↗MalfunctionMay 14, 2019Dent in Material; Dent in Material
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8609544 ↗MalfunctionApr 1, 2019Break; Break
ADDITIONAL INFORMATION RECEIVED ON 01APR2019. IT IS INCONVENIENT TO OFFER THE PERSONAL PRIVACY INFORMATION FOR THE PATIENT, IT WAS FOUND BEFORE THE PROCEDURE. AFTER REPLACING A NEW PRODUCT THE PROCEDURE WAS COMPLETED, THERE WAS NO ADVERSE EFFECTS BE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8470520 ↗MalfunctionApr 12, 2018Crack
IT WAS REPORTED THAT WHEN THE PHYSICIAN OPENED THE URETERAL STENT SET, THEY FOUND A FISSURE IN THE FRONT END OF THE STENT. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND THERE WAS NO IMPACT TO THE PATIENT OR USERS.
Patient problems: No Patient Involvement
MAUDE report 7426705 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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