Cook G31478Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002314788), received between Nov 6, 2018 and Aug 21, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8917808 ↗
• MalfunctionNov 6, 2018Material Separation; Material Separation

  IT WAS REPORTED A RING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY NEEDLE WAS USED DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE. WHEN ATTEMPTING TO ANGLE THE NEEDLE INTO THE TARGET SITE, THE NEEDLE WOULD NOT TURN (NO DIFFICULTY WITH INSERTION PER THE CUSTOMER). THE DEVICE WAS REMOVED FROM THE PATIENT AND THE NEEDLE TIP SEPARATED INTO THE STERILE FIELD. NO PORTION OF THE DEVICE REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEEDLE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8042768 ↗