Cook G03266Recalls & 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 00827002032668), received between Sep 26, 2017 and Nov 9, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
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 Leak2
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.
InjuryNov 9, 2017Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT, WHEN THE OPERATOR WAS INJECTING SALINE THROUGH THE SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC), SOME OF THE SALINE PROCEEDED TO SQUIRT THROUGH A DEFECT IN THE PICC AND INTO THE OPERATOR'S EYE. THE PICC LINE WAS THEN REMOVED FROM THE PATIENT. THE DEFECT WAS OBSERVED TO BE APPROXIMATELY 4 CM AWAY FROM THE INJECTING HUB OF THE LINE. THE LINE WAS REPORTEDLY INSERTED UNEVENTFULLY ON (B)(6) 2017, AND HAD BEEN USED WITHOUT COMPLICATION UP UNTIL THAT POINT. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN.
Patient problems: No Code Available
MAUDE report 7015304 ↗MalfunctionSep 26, 2017Fluid/Blood Leak
THE DEVICE LEAKED AT THE JUNCTION OF THE CATHETER AND THE HUB. NO DAMAGE WAS SUFFERED BY THE CHILDREN AFFECTED BESIDES HAVING TO HAVE AN EXTRA PUNCTURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6893324 ↗
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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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