Cook G04891Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002048911), received between Mar 21, 2017 and Jan 2, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057848 ↗
• MalfunctionJan 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS EVENT NO LONGER MEETS THE DEFINITION OF A REPORTABLE COMPLAINT. SEE H10

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057847 ↗
• MalfunctionMar 11, 2024Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2024 DETAILING THAT THE THREE INCIDENTS OF THE WIRE GUIDE FRAYING ALL OCCURRED ON THE SAME PATIENT ON THE SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 18875244 ↗
• MalfunctionAug 17, 2017Crack

  PRIOR TO THE PROCEDURE IT WAS NOTICED THAT THERE WAS A CRACK IN THE TIP OF THE INTRODUCER. THE COMPLETE SET WAS REMOVED FROM TABLE AND A NEW SET WAS USED WITH A DIFFERENT LOT NUMBER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENTS¿ BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6801102 ↗
• MalfunctionAug 15, 2017Crack

  PRIOR TO THE PROCEDURE A CRACK WAS NOTED ON THE TIP OF THE DILATOR. ONE OTHER CRACKED UNUSED DILATOR WAS ALSO FOUND. A DILATOR FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6794628 ↗
• MalfunctionMar 21, 2017Split; Split

  INTERNATIONAL CUSTOMER REPORTED THAT THE PLACEMENT OF A THAL-QUICK CHEST TUBE WENT WELL UNTIL THE LAST DILATOR (THE BIGGEST DILATOR) WAS PLACED OVER THE GUIDE WIRE. CUSTOMER STATED THAT THE DILATOR LOOKED CURVED AT THE TAPERED PORTION AND THE END HOLE APPEARED NARROW. THE TIP OF THE DILATOR PARTED (SPLIT) DURING USE. IT IS NOT KNOWN WHAT ACTIONS WERE TAKEN UPON NOTING THE ISSUE. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES RELATED TO THIS EVENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; THE DEVICE HAS NOT BEEN RECEIVED AS OF THIS DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6420249 ↗