Universa G53235Recalls & reported problems
Cook Incorporated · Universa, Silicone Foley Catheter 3-Way Closed End · Class 2
All models of Universa (82)
Data updated Oct 16, 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 00827002532359), received between Apr 21, 2017 and Apr 21, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).
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.
Most reported problems
Device problems
- Migration or Expulsion of Device1
- Torn Material1
Patient problems
- Swelling1
- Swollen Glands1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2017Migration or Expulsion of Device; Torn Material; Migration or Expulsion of Device; Torn Material
IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE USING A UNIVERSA SILICONE FOLEY CATHETER. THE REPORT INDICATED THAT THE PATIENT WAS SUFFERING FROM HAEMATURIA. ON (B)(6) 2017 A UNIVERSA SILICONE FOLEY CATHETER WAS IMPLANTED AT 10H00 AND BY 16H00 THE CATHETER WAS FOUND IN THE PATIENT¿S BED. THE BALLOON ¿CUT IN ITS LENGTH¿. LATER, AT 18H00 A NEW CATHETER IMPLANTED AND BY 20H30 THE CATHETER WAS FOUND IN THE PATIENT¿S BED ONCE AGAIN. THE BALLOON ¿CUT IN ITS LENGTH¿. FINALLY, ON THE MORNING OF (B)(6) 2017 AT 05H00 A NEW UNIVERSA SILICONE FOLEY CATHETER WAS IMPLANTED AND THE PATIENT¿S BLADDER WAS DISCOVERED TO BE SWOLLEN. BY 08H00 THE DEVICE WAS FOUND IN THE PATIENT¿S BED AND THE BALLOON ¿CUT IN ITS LENGTH¿. NO FURTHER INFORMATION WAS PROVIDED, ADDITIONALLY QUESTIONS HAVE BEEN SENT TO THE CUSTOMER FOR CLARIFICATION. THIS MEDWATCH IS FOR ONE OUT OF THREE UNIVERSA SILICONE FOLEY CATHETER IN QUESTION, REFERENCE MFR 1820334-2017-00847 FOR THIS COMPLAINT FILE. THE OTHER TWO REMAINING UNIVERSA SILICONE FOLEY CATHETER IN QUESTION; REFERENCE: 1820334-2017-00845 AND 1820334-2017-00846.
Patient problems: Swelling; Swollen Glands
MAUDE report 6511483 ↗
Other CATHETER, RETENTION TYPE, BALLOON devices
- Bardex® All-Silicone Foley Catheter 165816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON512 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON476 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI16C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 death383 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON234 reports
- Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119216MC. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON167 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175814C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON153 reports
- Bardex® All-Silicone Foley Catheter 165812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON151 reports
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter Tray A942216C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON2 recalls46 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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