Cook G03267Recalls & 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 00827002032675), received between Sep 27, 2017 and Sep 27, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
- Device Operates Differently Than Expected1
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 27, 2017Device Operates Differently Than Expected
DURING RETRIEVAL, THE CLAMP WHICH FUNCTIONS TO RELEASE THE DEVICE WAS NOT WORKING, SO ANOTHER CLAMP WAS REQUIRED TO REMOVE THE PEEL AWAY SHEATH AS ITS TABS WERE BEING RELEASED. THE PHYSICIAN USED ANOTHER PRODUCT TO FINISH THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS INCIDENT.
Patient problems: No Code Available
MAUDE report 6896953 ↗
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- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
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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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