Cook G08519Recalls & 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 00827002085190), received between Mar 29, 2017 and Mar 29, 2017 — classified as 1 injury.
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
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.
InjuryMar 29, 2017Break; Break
INTERNATIONAL CUSTOMER REPORTED THAT A DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) WAS IMPLANTED ON (B)(6) 2017 FOR AN UNSPECIFIED INDICATION. THE CUSTOMER REPORTED THAT THE BROKE AT THE CLAMP LEVEL. THE DEVICE WAS EXPLANTED ON (B)(6) 2017. THE HANDLING CONDITIONS AND CIRCUMSTANCES SURROUND THE REPORTED BREAK ARE NOT KNOWN. THE PATIENT REPORTEDLY HAD AN UNSPECIFIED ADDITIONAL PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THE DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: No Code Available
MAUDE report 6443217 ↗
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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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