COOK G47451Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002474519), received between Jan 27, 2022 and Feb 15, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: PT CAME IN EMERGENTLY DUE TO RUPTURE. (B)(6) (B)(6) 2022 ((B)(4)) THE FIRST DEVICE (G47452, LOT E4201640) DID NOT LAND IN THE RIGHT PLACE DUE TO OPERATOR ERROR. A LACK OF UPWARD FORCE IN HOLDING THE DEVICE INTO POSITION CAUSED THE PROBLEM. ON ((B)(6)) THEY HAD TO USE SECOND DEVICE (G47451, LOT E4202793) BECAUSE THE FIRST DEVICE WAS NOT IN THE PROPER PLACE. WHEN THEY TRIED TO USE THE SECOND DEVICE, THE TRIGGER WIRES COULD NOT BE PULLED OUT. THEY USED AS MUCH FORCE AS THEY COULD USE. THEY THEN INTENTIONALLY BROKE APART THE DEVICE TO GET AHOLD OF THE WIRES TO RELEASE THE GRAFT FROM THE DELIVERY SYSTEM. WHILE RETRACTING THE WIRES, THE GRAFT WAS PUSHED BACK OUT OF PLACE BY BLOOD FLOW FORCES. IT WAS NOT SITTING CORRECTLY WITHIN THE FIRST DEVICE. ((B)(4)) A THIRD DEVICE (G47470, LOT E3923818) WOULD NOT TRACK UP BECAUSE OF THE WAY THAT THE SECOND DEVICE WAS PLACED. THE PROCEDURE WAS THEN ABORTED. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE AN ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT LOST 1.5 UNITS OF BLOOD AND DID NOT ACHIEVE PROXIMAL SEAL. UNKNOWN IF THE PATIENT DID REQUIRE AN ADDITIONAL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13534327 ↗
• InjuryJan 27, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: PT CAME IN EMERGENTLY DUE TO RUPTURE. ON (B)(6) 2022 ((B)(4)) THE FIRST DEVICE ((B)(4), LOT E4201640) DID NOT LAND IN THE RIGHT PLACE DUE TO OPERATOR ERROR. A LACK OF UPWARD FORCE IN HOLDING THE DEVICE INTO POSITION CAUSED THE PROBLEM. ((B)(4)) THEY HAD TO USE SECOND DEVICE ((B)(4), LOT E4202793) BECAUSE THE FIRST DEVICE WAS NOT IN THE PROPER PLACE. WHEN THEY TRIED TO USE THE SECOND DEVICE, THE TRIGGER WIRES COULD NOT BE PULLED OUT. THEY USED AS MUCH FORCE AS THEY COULD USE. THEY THEN INTENTIONALLY BROKE APART THE DEVICE TO GET AHOLD OF THE WIRES TO RELEASE THE GRAFT FROM THE DELIVERY SYSTEM. WHILE RETRACTING THE WIRES, THE GRAFT WAS PUSHED BACK OUT OF PLACE BY BLOOD FLOW FORCES. IT WAS NOT SITTING CORRECTLY WITHIN THE FIRST DEVICE. ((B)(4)) A THIRD DEVICE ((B)(4), LOT E3923818) WOULD NOT TRACK UP BECAUSE OF THE WAY THAT THE SECOND DEVICE WAS PLACED. THE PROCEDURE WAS THEN ABORTED. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE AN ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT LOST 1.5 UNITS OF BLOOD AND DID NOT ACHIEVE PROXIMAL SEAL. UNKNOWN IF THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDU

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13368796 ↗