Ring G06541Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002065413), received between Nov 15, 2019 and Nov 15, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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.

Recalls naming this device

1. Nov 26, 2025Open, Classified

   Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

   Z-0994-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2019Material Puncture/Hole; Material Separation; Material Puncture/Hole; Material Separation

  IT WAS REPORTED A RING TRANSJUGULAR INTRAHEPATIC ACCESS SET WAS USED IN A FEMALE PATIENT FOR A ENDOLUMINAL GRAFT ABDOMINAL AORTIC ANEURYSM ENDOLEAK REPAIR PROCEDURE. THE OPERATOR NOTICED A HOLE ON THE TEFLON CATHETER "A COUPLE CENTIMETERS FROM THE TIP". THE TIP OF THE CATHETER HAD "A LITTLE PIECE SHEER-OFF" OUTSIDE OF THE PATIENT, AND THE PHYSICIAN "CLIPPED OFF THE PIECE". A NEW, SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9329928 ↗