Cook G08664Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002086647), received between Aug 16, 2016 and Apr 16, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fluid/Blood Leak1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 16, 2019Fluid/Blood Leak; Fluid/Blood Leak
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Code Available
MAUDE report 8518186 ↗MalfunctionAug 16, 2016Break; Break
IT WAS REPORTED DURING INSERTION OF A PICC LINE THE NURSE TESTED THE PICC LINE AND THE PLASTIC CLAMP WHICH STOPS THE PICC FROM DIGGING INTO THE PATIENT SNAPPED IN TWO. REPORTEDLY THE LINE WAS PLACED OVER THE WIRE INTO THE PATIENT'S ARM FOR CHEMOTHERAPY TREATMENT AND WAS EASILY REMOVED AND SUCCESSFULLY REPLACED WITH ANOTHER PICC LINE PACKET AS THE WIRE WAS STILL IN PLACE. 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 Known Impact Or Consequence To Patient
MAUDE report 5878240 ↗
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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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