Universa G49898Recalls & reported problems
Cook Incorporated · Universa Firm Ureteral Stent and Positioner With Hydrophilic Coating · Class 2 · Implant
All models of Universa (82)
Data updated Oct 16, 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 10827002498980), received between Jan 20, 2020 and Aug 27, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation3
- Break1
- Crack1
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2024Break; Break
IT WAS REPORTED THE 'UNIVERSA FIRM URETERAL STENT' TIP OF THE SENT WAS BROKEN UPON OPENING PRIOR TO AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. A CUSTOMER PROVIDED PHOTO APPEARS TO SHOW THE PIGTAIL SEPARATED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20076812 ↗MalfunctionMay 5, 2023Material Twisted/Bent; Material Twisted/Bent
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 16877137 ↗MalfunctionAug 12, 2021Material Separation; Material Separation
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12317047 ↗MalfunctionMay 10, 2021Material Separation; Material Separation
IT WAS REPORTED THAT, PRIOR TO PATIENT CONTACT, THE STENT FROM A UNIVERSA FIRM URETERAL STENT SET WAS FOUND TO BE SEPARATED, AND THE TETHER WAS DETACHED FROM THE STENT WHEN THE PACKAGE WAS OPENED. THE DEVICE WAS STORED IN A COOL, VENTILATED, DRY PLACE. THE USER USED A NEW DEVICE TO FINISH THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11798462 ↗MalfunctionApr 9, 2021Material Separation; Material Separation
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11644477 ↗MalfunctionAug 27, 2020Material Deformation; Material Deformation
IT WAS REPORTED, DURING AN UNKNOWN PROCEDURE USING A UNIVERSA FIRM URETERAL STENT SET, THE OPERATOR OPENED THE POUCH AND FOUND THE PIGTAIL WAS DEFORMED. THE PROCEDURE WAS COMPLETED BY USING A NEW STENT. NO ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10463830 ↗MalfunctionJan 20, 2020Crack; Crack
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9606906 ↗
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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