Cook G13260Recalls & reported problems
Cook Incorporated · Polyethylene Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002132603), received between Dec 17, 2018 and Dec 17, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2018Material Split, Cut or Torn
THE COMPLAINANT REPORTED THAT THE POLYETHYLENE ANGIOGRAPHIC CATHETER WAS OPENED AND NOTED TO BE STRETCHED JUST PAST THE HUB PRIOR TO PLACING THE CATHETER IN THE PATIENT. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. IT WAS FURTHER NOTED THAT THE CATHETER WAS ALSO SPLIT. THE PRODUCT PROBLEM(S) DID NOT LEAD TO ANY REPORTED PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8169184 ↗
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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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