Cook G29773Recalls & reported problems
Cook Incorporated · Multipurpose Drainage Catheter Ultrathane · Class U · Implant
- 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 00827002297739), received between Jul 3, 2017 and Jul 3, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
InjuryJul 3, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTED THAT A PATIENT RECEIVED AN ULTRATHANE MULTIPURPOSE DRAINAGE CATHETER FOR UNSPECIFIED DRAINAGE ON (B)(6) 2017. THE HUB FELL OFF THE DEVICE FOUR DAYS LATER. THE CIRCUMSTANCES AND HANDLING CONDITIONS LEADING TO THE EVENT ARE NOT KNOWN. THE DEVICE WAS COMPLETELY EXPLANTED AND REPLACED WITH A NEW CATHETER. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Code Available
MAUDE report 6683927 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.