COOK G47448Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002474489), received between Apr 8, 2022 and Dec 22, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2023Off-Label Use; Physical Resistance/Sticking; Off-Label Use; Physical Resistance/Sticking

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A REPAIR OF A CHRONIC DISSECTION WITH EXISTING PROXIMAL STENT GRAFT IN WHICH THE ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT, G47448, WAS USED. THE GRAFT WAS BEING DEPLOYED INSIDE AN EXISTING SURGICAL GRAFT FROM ANOTHER MANUFACTURER. THERE WAS NO NOTABLE TORTUOSITY OR ANGULATION. THE DEVICE DEPLOYED FINE AND AS INTENDED, HOWEVER THE SAFETY WIRE RELEASE WAS EXTREMELY DIFFICULT TO RELEASE. ANOTHER UNIT OF THE SAME, G47448- LOT E4468992, WAS PLACED DISTALLY WITH NO ISSUES ON RELEASE OR DEPLOYMENT. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388843 ↗
• MalfunctionApr 5, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PHYSICIAN HAD A VERY DIFFICULTY TIME RELEASING THE SAFETY WIRE. THE PHYSICIAN WAS UNHAPPY WITH AMOUNT OF FORCE REQUIRED TO SUCCESSFULLY RELEASE THE SAFETY WIRE. THE DEVICE WAS EVENTUALLY DEPLOYED, PER IFU (INSTRUCTIONS FOR USE). THERE WAS NO SEVERE TORTUOSITY. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16680769 ↗
• InjuryApr 8, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: AFTER FULLY UNSHEATHING OF ZDEG, WHITE THUMBSCREW WAS REMOVED FROM GREEN TRIGGER WIRE MECHANISM & PHYSICIAN ATTEMPTED PULLED GREEN TRIGGER MECHANISM. MECHANISM WOULD NOT COME OFF. HAD TO TROUBLESHOOT TO REMOVE WIRES, DISLODGING GRAFT FROM ORIGINAL LANDING ZONE. PUT ANOTHER PIECE IN FOLLOWING. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14052778 ↗
• InjuryApr 8, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: AFTER FULLY UNSHEATHING OF ZDEG, WHITE THUMBSCREW WAS REMOVED FROM GREEN TRIGGER WIRE MECHANISM & PHYSICIAN ATTEMPTED PULLED GREEN TRIGGER MECHANISM. MECHANISM WOULD NOT COME OFF. HAD TO TROUBLESHOOT TO REMOVE WIRES, DISLODGING GRAFT FROM ORIGINAL LANDING ZONE. PUT ANOTHER PIECE IN FOLLOWING. (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14049467 ↗