Cook G00003Recalls & reported problems
Cook Incorporated · Percutaneous Entry Thinwall Needle One-Part · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002000032), received between May 7, 2018 and Jan 21, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Bent” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Bent1
- Delivered as Unsterile Product1
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 8264214 ↗MalfunctionMay 7, 2018Bent; Bent
IT WAS REPORTED THE ONE-PART PERCUTANEOUS ENTRY NEEDLE WAS NOTED TO BE BENT AS IT WAS REMOVED FROM IT'S PACKAGING. THE DEVICE WAS NOT USED DURING A PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE
Patient problems: No Patient Involvement
MAUDE report 7492090 ↗
Other Trocar devices
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- BRK™ 407200St. Jude Medical Cardiovascular Division · Trocar4 deaths71 reports
- NA EP003994SMedtronic, Inc. · Trocar60 reports
- Cook G02364Cook Incorporated · Trocar1 recall5 reports
- HeartSpan® 00884450489345Merit Medical Systems, Inc. · Trocar1 recall1 death2 reports
- Cook G01377Cook Incorporated · Trocar1 recall2 reports
- HeartSpan® 00884450489369Merit Medical Systems, Inc. · Trocar1 recall0 reports
- Endrys G19261Cook Incorporated · Trocar1 recall0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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