Cook G08520Recalls & reported problems
Cook Incorporated · Peripherally Inserted Central Venous Catheter Set Silicone · Class 2 · Implant
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 00827002085206), received between Sep 26, 2017 and Sep 26, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Hole In Material1
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.
InjurySep 26, 2017Fluid/Blood Leak; Hole In Material
IT WAS REPORTED THE NURSES DISCOVERED A PIN PRICK HOLE IN THE CATHETER NEAR THE CLAMP ON THE YELLOW LUMEN SIDE. IT WAS INSERTED THE DAY BEFORE AND THEY NOTICED A LEAK DURING TREATMENT THEN IT BECAME BLOCKED. AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED THE NEXT DAY.
Patient problems: No Code Available
MAUDE report 6895164 ↗
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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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