Cook G08663Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002086630), received between Jan 23, 2017 and Jul 12, 2019 — classified as 1 injury, 2 malfunctions.
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
- Leak/Splash1
- Obstruction of Flow1
Patient problems
- No Consequences Or Impact To Patient2
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AFTER THE INSERTION OF A PICC LINE, LEAKAGE WAS OBSERVED FROM THE TUBING OF THE SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER. THE PHYSICIAN DISCARDED THE LEAKING CATHETER AND USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE DEVICE WAS FLUSHED BEFORE PLACEMENT. NO PHOTOS OF THE DEVICE WERE AVAILABLE FOR RETURN. AS REPORTED, THERE WERE NO ADVERSE EFFECTS EXPERIENCED BY THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8784857 ↗MalfunctionMay 24, 2019Obstruction of Flow; Obstruction of Flow
NO ADDITIONAL EVENT INFORMATION HAS BEEN REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8640448 ↗InjuryJan 23, 2017Leak/Splash; Leak/Splash
CUSTOMER REPORTED THAT A LEAK WAS OBSERVED AT THE JUNCTION OF THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) CATHETER HUB FOUR (4) DAYS FOLLOWING INITIAL INSERTION OF THE LINE. THE DEVICE WAS REMOVED AND REPLACED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Code Available
MAUDE report 6269423 ↗
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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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