Cook G01377Recalls & reported problems
Cook Incorporated · Trocar Needle · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002013773), received between Nov 1, 2017 and Nov 5, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Mar 1, 2024Open, Classified
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Z-1526-2024 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Device Operates Differently Than Expected1
- Difficult to Advance1
- Difficult to Remove1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance
IN ADDITIONAL INFORMATION RECEIVED ON 13NOV2025, IT WAS CONFIRMED THAT THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23478076 ↗InjuryNov 1, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING A LITHOTRIPSY PROCEDURE, A TROCAR NEEDLE WAS EMPLOYED TO PROVIDE ROUTINE ACCESS TO THE PATIENT'S KIDNEY. A ZIPWIRE BRAND GUIDEWIRE (WHICH WAS NOT OF COOK MANUFACTURE) WAS THEN THREADED THROUGH THE TROCAR NEEDLE, WHICH WAS ALSO REPORTEDLY PER PROCEDURE. WHEN THE PHYSICIAN BEGAN TO PULL THE GUIDE WIRE OUT OF THE ASSEMBLY, THE TROCAR PEELED THE ZIP WIRE AND CUT SOME OF THE EDGES OF THE WIRE OFF. THESE PIECES DISENGAGED INTO THE PATIENT'S CAVITY, BUT WERE SUCCESSFULLY REMOVED IN THEIR ENTIRETY BY THE OPERATOR. THE ONLY UNEXPECTED OUTCOME FOR THE PATIENT WAS AN EXTENSION TO THE SURGERY TIME OF ABOUT 20 MINUTES. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.
Patient problems: No Code Available
MAUDE report 6993079 ↗
Other Trocar devices
- BRK™ G407208St. Jude Medical Cardiovascular Division · Trocar3 deaths75 reports
- 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
- HeartSpan® 00884450489369Merit Medical Systems, Inc. · Trocar1 recall0 reports
- Endrys G19261Cook Incorporated · Trocar1 recall0 reports
- BRK-1™ G407209St. Jude Medical Cardiovascular Division · Trocar4 deaths50 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 · each recall links to the FDA recall notice
- 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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