Cook G00511Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002005112), received between Dec 15, 2016 and Mar 13, 2025 — classified as 6 malfunctions.

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

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.

Recalls naming this device

1. Aug 16, 2022Open, Classified

   Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

   Z-1833-2022 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionMar 13, 2025Flaked; Flaked

  AS REPORTED, DURING A PERICARDIOCENTESIS PROCEDURE, A SAFE-T-J FIXED CORE WIRE GUIDE BECAME STUCK WITHIN AN UNKNOWN SHEATH. THE WIRE HOLDER WAS FLUSHED AND/OR THE WIRE WAS PLACED IN A BOWL OF HEPARINIZED SALINE OR STERILE WATER PRIOR TO USE. THE WIRE WAS NOT ALTERED PRIOR TO USE. THE ANATOMY WAS NOT SCARRED. THE WIRE WAS NOT DIFFICULT TO ADVANCE INTO THE SHEATH; HOWEVER, IT WAS DIFFICULT TO REMOVE FROM THE SHEATH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, PART OF THE COATING WAS MISSING FROM THE WIRE GUIDE AT THE LOCATION OF A KINK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596933 ↗
• MalfunctionJun 13, 2024Device 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 19532194 ↗
• MalfunctionSep 1, 2023Stretched; Unraveled Material; Material Protrusion/Extrusion; Stretched; Unraveled Material; Material Protrusion/Extrusion

  ADDITIONAL INFORMATION, RECEIVED 30AUG2023, WAS INADVERTENTLY OMITTED FROM THE INITIAL MDR. THE WIRE ADVANCED THROUGH A CATHETER WITHOUT TROUBLE; HOWEVER, THE WIRE "FRAYED" UPON REMOVAL. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE ON 13SEP2023, THE WIRE WAS UNRAVELED/STRETCHED/ELONGATED. THE MANDRIL AND SAFETY WIRE WERE SEPARATED AND PROTRUDED FROM THE OUTER COILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670739 ↗
• MalfunctionApr 11, 2023Sharp Edges; Sharp Edges

  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 16715979 ↗
• MalfunctionFeb 15, 2023Material Frayed; Unraveled Material; Material Frayed; Unraveled Material

  ADDITIONAL INFORMATION RECEIVED 03MAR2023. THE WIRE WAS NOT ALTERED FROM ITS ORIGINAL CONDITION. THE PATIENT WAS NOT HOSPITALIZED NOR WAS HOSPITALIZATION PROLONGED DUE TO THIS OCCURRENCE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16379371 ↗
• MalfunctionDec 15, 2016Material Separation; Material Separation

  (B)(4). "A J WIRE WAS USED DURING A CT GUIDED PANCREATIC DRAIN INSERTION ON SUNDAY ((B)(6) 2016). A SMALL FOREIGN BODY WAS NOTED IN THE COLLECTION WHEN REVIEWING THE SCANS THE FOLLOWING DAY. IT WAS NOT NOTICED THAT PART OF THE WIRE WAS MISSING AT ANY POINT IN THE PROCEDURE POST REMOVAL OF THE WIRE AND IT HAS BEEN NOTED THAT THE J SHAPE WAS STILL INTACT. UPON REVIEWING THE IMAGES THE ONLY PLAUSIBLE EXPLANATION AT THIS STAGE IS THAT THE DISTAL END OF THE J-WIRE SNAPPED WHILST THE DRAIN WAS BEING FORMED. IT IS UNLIKELY TO CAUSE ANY HARM AS IT¿S IN THE COLLECTION. A PLAN HAS BEEN DISCUSSED TO REMOVE IT SAFELY. THE J-WIRE REMOVED FROM THE PATIENT IS BELIEVED TO BE IN AN ALMOST FULL LARGE SHARPS BIN WHICH HAS BEEN SEALED AND LABELED." NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6178393 ↗