Universa G55801Recalls & reported problems
Cook Incorporated · Universa Loop Drainage Catheter Introductory Set · Class U
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 00827002558014), received between May 2, 2018 and May 2, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Component Missing” (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
- Component Missing1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 2, 2018Component Missing; Component Missing
IT WAS REPORTED THAT WHEN THE SURGEON OPENED THE UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER SET, THE NEEDLE WAS MISSING AND THEY DIDN'T HAVE ANOTHER NEEDLE IN STOCK AS THE OTHER SETS THEY HAD WITH THE SAME LOT NUMBER WERE ALSO MISSING THEIR NEEDLES. THE PUNCTURE PART OF THE PROCEDURE COULD NOT BE CARRIED OUT AS A RESULT. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THEY HAD TO CANCEL THE CASE AND TO RESCHEDULE THE PATIENT LATER WHEN THEY COULD GET EQUIPMENT FROM ANOTHER HOSPITAL. THE KIT DOES NOT CONTAIN A PUNCTURE NEEDLE YET THE LISTING OF CONTENTS INDICATES A 18 G X 20 CM NEEDLE. UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT THE NEEDLE LISTED IN THE BILL OF MATERIALS WAS MISSING FROM THE SET. THIS ACCOUNT HAD A TOTAL OF SEVEN DEVICES FROM THE SAME LOT NUMBER THAT WERE MISSING THE NEEDLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 7481007 ↗
Other CATHETER, NEPHROSTOMY devices
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- Dawson Mueller G09705Cook Incorporated · CATHETER, NEPHROSTOMY2 deaths215 reports
- Cook G09497Cook Incorporated · CATHETER, NEPHROSTOMY129 reports
- Dawson Mueller G11020Cook Incorporated · CATHETER, NEPHROSTOMY100 reports
- Cook G09502Cook Incorporated · CATHETER, NEPHROSTOMY86 reports
- NephroMax Kit M0062101180Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall25 reports
- NephroMax Kit M0062101600Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall11 reports
- Cook G09767Cook Incorporated · CATHETER, NEPHROSTOMY1 recall9 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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