COOK G47440Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002474403), received between Jan 3, 2023 and Jan 11, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT CAME IN FOR A DISSECTION EMERGENT CASE. DURING DEPLOYMENT OR USER AGGRESSION THE GRAFT LANDED DISTAL TO WHERE THE ACTUAL APPROX LANDING ZONE WANTED TO BE ((B)(4)). THE PHYSICIAN DECIDED TO USE A DEVICE FROM ANOTHER MANUFACTURER TO GET MORE OF A PROXIMAL SEAL. DELIVERED THE DEVICE THEN DISTALITY HE EXTENDED OUT THE ZDES-36-180-US. UPON FINAL RUN HE WAS SATISFIED WITH THE FINAL ANGIO. FAST FORWARD TO RECENTLY WITHIN THE LAST WEEK THE PATIENT HAD TO COME BACK IN WITH A TYPE A DISSECTION TO WHERE THEY HAD TO BUILD THE ARCH ((B)(4)). PATIENT OUTCOME: THE PATIENT WAS PROLONGED HOSPITALIZED FOR RECOVERY. FURTHERMORE, THE PATIENT HAD TO RETURN FOR COMPLETE ARCH REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16141838 ↗
• InjuryJan 3, 2023Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT CAME IN FOR A DISSECTION EMERGENT CASE. DURING DEPLOYMENT OR USER AGGRESSION THE GRAFT LANDED DISTAL TO WHERE THE ACTUAL APPROX LANDING ZONE WANTED TO BE ((B)(4)). THE PHYSICIAN DECIDED TO USE A DEVICE FROM ANOTHER MANUFACTURER TO GET MORE OF A PROXIMAL SEAL. DELIVERED THE DEVICE THEN DISTALITY HE EXTENDED OUT THE ZDES-36-180-US. UPON FINAL RUN HE WAS SATISFIED WITH THE FINAL ANGIO. FAST FORWARD TO RECENTLY WITHIN THE LAST WEEK THE PATIENT HAD TO COME BACK IN WITH A TYPE A DISSECTION TO WHERE THEY HAD TO BUILD THE ARCH ((B)(4)). PATIENT OUTCOME: THE PATIENT WAS PROLONGED HOSPITALIZED FOR RECOVERY. FURTHERMORE, THE PATIENT HAD TO RETURN FOR COMPLETE ARCH REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085023 ↗
• InjuryJan 3, 2023Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT CAME IN FOR A DISSECTION EMERGENT CASE. DURING DEPLOYMENT OR USER AGGRESSION THE GRAFT LANDED DISTAL TO WHERE THE ACTUAL APPROX LANDING ZONE WANTED TO BE (PR384167). THE PHYSICIAN DECIDED TO USE A DEVICE FROM ANOTHER MANUFACTURER TO GET MORE OF A PROXIMAL SEAL, DELIVERED THE DEVICE THEN DISTALITY HE EXTENDED OUT THE ZDES-36-180-US UPON FINAL RUN HE WAS SATISFIED WITH THE FINAL ANGIO. FAST FORWARD TO RECENTLY WITHIN THE LAST WEEK THE PATIENT HAD TO COME BACK IN WITH A TYPE A DISSECTION TO WHERE THEY HAD TO BUILD THE ARCH (PR384229). PATIENT OUTCOME: THE PATIENT WAS PROLONGED HOSPITALIZED FOR RECOVERY. FURTHERMORE, THE PATIENT HAD TO RETURN FOR COMPLETE ARCH REPAIR.

  Patient problems: Vascular Dissection

  MAUDE report 16084903 ↗