Universa G17203Recalls & reported problems
Cook Incorporated · Universa, Silicone Foley Catheter Open-End · Class 2
All models of Universa (82)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002172036), received between Sep 25, 2018 and Dec 16, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2019Fracture; Fracture
IT WAS REPORTED THAT WHILE A PATIENT WAS BEING TREATED AT HOME, A UNIVERSA SILICONE FOLEY CATHETER WAS PLACED AND LATER BROKE ABOVE THE WATER PORT AND LEFT ABOUT 3 INCHES OF THE CATHETER PROTRUDING FROM THE PATIENT. IT IS CURRENTLY UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS REPORTED THAT IT WILL NOT BE AVAILABLE UNTIL ABOUT A MONTH FROM NOW DUE TO THE PATIENT BEING TREATED AT HOME. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THAT INFORMATION IS RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9475459 ↗MalfunctionSep 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED DURING THE HYPOSPADIAS REPAIR PROCEDURE, THE UNIVERSA SILICONE FOLEY CATHETER WAS INSERTED ON (B)(6) 2018 AROUND 12 NOON AND AT 9 PM THE FOLEY CATHETER CAME OUT AND BALLOON WAS DEFLATED. THE PATIENT HAD ANOTHER FOLEY CATHETER PLACED. NO OTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 7905662 ↗
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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