Cook G57485Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002574854), received between Aug 19, 2021 and Dec 18, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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.

• MalfunctionDec 18, 2023Material Separation; Material Separation

  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 18350266 ↗
• MalfunctionMay 11, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

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

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912694 ↗
• MalfunctionApr 27, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2023. THE ACCESS SITE WAS THE RIGHT INTERNAL JUGULAR VEIN. THE PART OF THE DEVICE THAT EXPERIENCED THE SEPARATION FAILURE WAS THE 5 FRENCH STRAIGHT CATHETER. THE SEPARATION OCCURRED DURING REMOVAL. NO PART OF THE CATHETER REMAINED IN THE SHEATH, CATHETER, OR PATIENT. NOTHING WAS CONNECTED TO THE FITTING, THE WIRE WAS INSIDE THE FITTING. NO FORCE WAS EXERTED ON THE SEPARATED FITTING OF THE CATHETER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827976 ↗
• MalfunctionFeb 14, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A HAIR-LIKE FIBER WAS DISCOVERED WITHIN THE SEALED PACKAGING OF A LIVER ACCESS AND BIOPSY SET. IT WAS CONFIRMED THAT THE DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375059 ↗
• InjuryJan 27, 2022Material Separation; Migration; Material Split, Cut or Torn; Material Separation; Migration; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE 5FR CATHETER INCLUDED IN THE LIVER ACCESS AND BIOPSY SET SHEARED OFF DURING A TRANSJUGULAR LIVER BIOPSY PROCEDURE AND REMAINED INSIDE THE PATIENT'S PULMONARY ARTERY. THE PHYSICIAN GAINED ACCESS TO THE HEPATIC VEIN USING AN MPB CATHETER AND BENTSON WIRE. THE BENTSON WIRE WAS THEN EXCHANGED FOR AN AMPLATZ EXTRA STIFF WIRE FOR STABILITY AND THE 7FR SHEATH WITH THE 5FR HYDROPHILIC CATHETER WAS ADVANCED OVER THE WIRE. FOLLOWING PLACEMENT IN THE TARGET LOCATION, AN ATTEMPT WAS MADE TO REMOVE THE 5FR CATHETER IN ORDER TO PREPARE FOR THE BIOPSY DEVICE. RESISTANCE WAS EXPERIENCED AND THEN SUBSIDED. UPON DEVICE REMOVAL, IT WAS DISCOVERED THAT 2 CM OF THE DISTAL PORTION OF THE 5FR CATHETER HAD SHEARED OFF. THE CATHETER TIP WAS VISUALIZED WITHIN THE LUMEN OF THE HEPATIC VEIN. AFTER THE BIOPSY WAS COMPLETED, RETRIEVAL OF THE FOREIGN BODY WAS ATTEMPTED. AFTER A COUPLE OF ATTEMPTS WITH A SNARE, THE CATHETER PIECE WAS DISLODGED AND COULD NO LONGER BE VISUALIZED. POST PROCEDURE X-RAYS WERE PERFORMED AND THE CATHETER TIP WAS VISUALIZED IN A TERMINATING PORTION OF THE RIGHT PULMONARY ARTERY. THE PHYSICIAN DISCUSSED THE ISSUE WITH THE PATIENT AND WILL FOLLOW UP WITH THE PATIEN

  Patient problems: Foreign Body In Patient

  MAUDE report 13367175 ↗
• MalfunctionAug 19, 2021Material Separation; Detachment of Device or Device Component; Material Deformation; Material Separation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THE DAMAGE WAS OBSERVED ON THE PROXIMAL AND DISTAL PORTIONS OF A LIVER ACCESS AND BIOPSY SET CATHETER. THE CATHETER WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT OR HARM. UPON REMOVAL, THE CATHETER WAS NOTED TO BE FRAYED AND THE LUER LOCK PORTION AT THE TOP HAD FALLEN OFF. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER ON 11AUG2021. A VISUAL INSPECTION CONFIRMED THAT THE 5FR STRAIGHT BLACK CATHETER HAD A DAMAGED/BUNCHED TIP AND THE HUB OF THE DEVICE WAS SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346027 ↗