UniversaRecalls & reported problems across all models
Cook Incorporated · 82 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 276
- Deaths reported
- 0
- Injuries reported
- 53
- Recalls
- 0
We found 82 models of Universa by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 276 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2014 and Sep 17, 2026 — classified as 53 injuries, 223 malfunctions.
The most frequently reported specific device problem is “Break” (75 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Universa problems
Device problems
- Break75
- Material Separation30
- Material Split, Cut or Torn23
- Device Damaged Prior to Use19
- Torn Material17
- Crack12
- Split11
- Fracture9
Patient problems
- No Consequences Or Impact To Patient101
- No Clinical Signs, Symptoms or Conditions67
- No Known Impact Or Consequence To Patient46
- No Code Available26
- No Patient Involvement24
- Insufficient Information8
- Device Embedded In Tissue or Plaque5
- Foreign Body In Patient5
Universa models
82 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Universa G49942STENT, URETERAL23 reports
- Universa G23406STENT, URETERAL22 reports
- Universa G49941STENT, URETERAL19 reports
- Universa G49945STENT, URETERAL15 reports
- Universa G49866STENT, URETERAL14 reports
- Universa G23405STENT, URETERAL12 reports
- Universa G49933STENT, URETERAL11 reports
- Universa G49874STENT, URETERAL8 reports
- Universa G49877STENT, URETERAL7 reports
- Universa G49934STENT, URETERAL7 reports
- Universa G49898STENT, URETERAL7 reports
- Universa G49906STENT, URETERAL7 reports
- Universa G49977STENT, URETERAL6 reports
- Universa G23404STENT, URETERAL5 reports
- Universa G23407STENT, URETERAL5 reports
- Universa G49973STENT, URETERAL5 reports
- Universa G53693STENT, URETERAL4 reports
- Universa G23374STENT, URETERAL4 reports
- Universa G49969STENT, URETERAL4 reports
- Universa G49974STENT, URETERAL4 reports
- Universa G17207CATHETER, RETENTION TYPE, BALLOON3 reports
- Universa G49937STENT, URETERAL3 reports
- Universa G23416STENT, URETERAL3 reports
- Universa G23417STENT, URETERAL3 reports
- Universa G49901STENT, URETERAL3 reports
- Universa G17203CATHETER, RETENTION TYPE, BALLOON2 reports
- Universa G32764CATHETER, RETENTION TYPE, BALLOON2 reports
- Universa G49873STENT, URETERAL2 reports
- Universa G49940STENT, URETERAL2 reports
- Universa G49950STENT, URETERAL2 reports
- Universa G49953STENT, URETERAL2 reports
- Universa G55803CATHETER, NEPHROSTOMY2 reports
- Universa G23367STENT, URETERAL2 reports
- Universa G23382STENT, URETERAL2 reports
- Universa G23383STENT, URETERAL2 reports
- Universa G23398STENT, URETERAL2 reports
- Universa G23399STENT, URETERAL2 reports
- Universa G23408STENT, URETERAL2 reports
- Universa G23415STENT, URETERAL2 reports
- Universa G49913STENT, URETERAL2 reports
- Universa G17205CATHETER, RETENTION TYPE, BALLOON1 report
- Universa G17512CATHETER, RETENTION TYPE, BALLOON1 report
- Universa G49867STENT, URETERAL1 report
- Universa G49872STENT, URETERAL1 report
- Universa G49932STENT, URETERAL1 report
- Universa G49943STENT, URETERAL1 report
- Universa G49957STENT, URETERAL1 report
- Universa G53229CATHETER, URETHRAL1 report
- Universa G53235CATHETER, RETENTION TYPE, BALLOON1 report
- Universa G53237CATHETER, RETENTION TYPE, BALLOON1 report
- Universa G53241CATHETER, RETENTION TYPE, BALLOON1 report
- Universa G53674STENT, URETERAL1 report
- Universa G53687STENT, URETERAL1 report
- Universa G53692STENT, URETERAL1 report
- Universa G53711STENT, URETERAL1 report
- Universa G55801CATHETER, NEPHROSTOMY1 report
- Universa G55802CATHETER, NEPHROSTOMY1 report
- Universa G55804CATHETER, NEPHROSTOMY1 report
- Universa G23240STENT, URETERAL1 report
- Universa G23313STENT, URETERAL1 report
- Universa G23316STENT, URETERAL1 report
- Universa G23369STENT, URETERAL1 report
- Universa G23377STENT, URETERAL1 report
- Universa G23381STENT, URETERAL1 report
- Universa G23384STENT, URETERAL1 report
- Universa G23397STENT, URETERAL1 report
- Universa G23422STENT, URETERAL1 report
- Universa G49897STENT, URETERAL1 report
- Universa G49899STENT, URETERAL1 report
- Universa G49905STENT, URETERAL1 report
- Universa G49907STENT, URETERAL1 report
- Universa G49908STENT, URETERAL1 report
- Universa G49909STENT, URETERAL1 report
- Universa G49965STENT, URETERAL1 report
- Universa G49972STENT, URETERAL1 report
- Universa G49976STENT, URETERAL1 report
- Universa G49981STENT, URETERAL1 report
- Universa G49982STENT, URETERAL1 report
- Universa G49991STENT, URETERAL1 report
- Universa G53700STENT, URETERAL1 report
- Universa G53701STENT, URETERAL1 report
- Universa G53704STENT, URETERAL1 report
Recent Universa adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Unraveled Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809176 ↗MalfunctionAug 5, 2026Unsealed Device Packaging
Additional information received on 23AUG2026 stating that the device was unsealed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50145047 ↗MalfunctionApr 30, 2026Break
IT WAS REPORTED THAT ONE END OF THE STENT FROM A UNIVERSA SOFT URETERAL STENT SET WAS FOUND TO BE SEPARATED AS THE NURSE WAS PREPARING THE DEVICE FOR A URETERAL STENT REPLACEMENT PROCEDURE. A NEW SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25046671 ↗MalfunctionFeb 17, 2026
6FR COOK MEDICAL STENT- TEAR IN THE STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24363961 ↗MalfunctionFeb 11, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE USER FOUND THE PACKAGING OF A UNIVERSA FIRM URETERAL STENT SET WAS NOT SEALED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24315593 ↗MalfunctionJan 5, 2026Break
IT WAS REPORTED, ONE OF THE PIGTAILS OF A UNIVERSA FIRM URETERAL STENT SET SEPARATED FROM THE STENT. THE ISSUE WAS DISCOVERED PRIOR TO PATIENT CONTACT AND THE DEVICE WAS NOT USED ON THE PATIENT. A NEW STENT WAS USED TO COMPLETE THE UNSPECIFIED PROCEDURE IN THE URETER. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23958196 ↗MalfunctionJan 5, 2026Break
IT WAS REPORTED THE STENT OF THE UNIVERSA FIRM URETERAL STENT SET BROKE DURING PLACEMENT IN THE URETER. THE BREAK WAS DETECTED WHEN THE USER ADJUSTED THE STENT¿S LOCATION AND NOTICED BREAKAGE AFTER PULLING THE STENT OUT SLIGHTLY. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23956912 ↗MalfunctionDec 4, 2025Break; 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 23717738 ↗MalfunctionOct 20, 2025Break; Break
IT WAS REPORTED THAT ONE END OF A STENT FROM A UNIVERSA FIRM URETERAL STENT SET WAS FRACTURED. DURING AN INSERTION OF THE URETERAL STENT PROCEDURE, THE USER NOTED ONE END OF THE STENT HAD A FRACTURE PRIOR TO USE. ANOTHER SIMILAR-LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23336530 ↗MalfunctionAug 21, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED: PROCEDURE WAS COMPLETED WITH A NEW DEVICE. IT IS UNKNOWN HOW THE STENT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22862683 ↗MalfunctionAug 13, 2025Break; 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 22794661 ↗MalfunctionMay 27, 2025Break; Break
IT WAS REPORTED A STENT FROM A UNIVERSA SOFT URETERAL STENT SET WAS FOUND BROKEN AT THE TIP AROUND 1 CM WITH THE TETHERS STILL ON IT, PRIOR TO AN UNSPECIFIED PROCEDURE. THE DEVICE WAS NOT INSERTED INTO THE PATIENT AND THE ISSUE WAS DISCOVERED WHEN THE USER WAS PREPARING IT FOR IMPLANT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-TYPE DEVICE. 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 22089916 ↗MalfunctionJan 13, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THE UNIVERSA FIRM URETERAL STENT SET'S STENTS HAD SOME SORT OF WHITISH FILM WHEN THEY REMOVE FROM THE STERILIZED PACKAGING PRIOR TO USE IN AN UNKNOWN PROCEDURE. CUSTOMER PROVIDED TWO VIDEOS APPEARING TO SHOW A STENT BEING PLACED IN A BASIN OF CLEAR FLUID AND THEN THE STRAIGHTENER BEING USED TO STRAIGHTEN OUT THE STENT PIGTAILS. THE VIDEO THEN FOCUSES ON THE TIP OF THE STRAIGHTENER WHERE A SEMI TRANSLUCENT MATERIAL APPEARS TO HAVE ACCUMULATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 21139161 ↗MalfunctionDec 9, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED IN THE UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER'S SEALING PACKAGE CONTAINED FOREIGN MATTER (A HAIR) PRIOR TO AN UNSPECIFIED PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 20880149 ↗MalfunctionNov 21, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THE 'UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETERS' THE WIRE GUIDE "DETACHED" FROM THE DEVICE DURING THE NEPHROSTOMY PROCEDURE. THE ISSUE WAS FOUND DURING DEVICE PLACEMENT, AND NO OTHER DEVICES WERE USED WITH THE WIRE GUIDE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20749334 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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