Cook brand Zenith Flex AAA Endovascular graft with the… recallZ-0517-05 · Cook, Inc. · initiated Dec 20, 2004

Why it was recalled

The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft.

FDA root cause category: Other

What the company is doing

Recall letter dated 12/20/04 was issued to each consignee via FedEx instructing them to cease using the products and to return them to the firm.

Recall details

Recall number

Z-0517-05

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Dec 20, 2004

Posted by the FDA

Feb 3, 2005

Recalling firm

Cook, Inc.

Product code

MIH

FDA submissions

P020018

Distribution

Nationwide and Canada.

Product description

Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 24mm, B=155mm, C=125mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-24-125.

Other devices under the same FDA submission

36 devices cleared under P020018 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Zenith G32551

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 deaths44 reports
• Zenith G32543

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  6 deaths18 reports
• Zenith G32554

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths17 reports
• Zenith G32542

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death15 reports
• Zenith G32539

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  14 reports
• Zenith G32537

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death13 reports
• Zenith G32538

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths13 reports
• Zenith G32544

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths9 reports
• Zenith G32533

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death8 reports
• Zenith G32532

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  7 reports
• Zenith G32550

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths7 reports
• Zenith G32534

  William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths6 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 30721).

• Z-0498-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System ( A= 22mm, B=112mm, C=82mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-8…
• Z-0499-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 24mm, B=112mm, C=82mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-24-82…
• Z-0500-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=112mm, C=82mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-82…
• Z-0501-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-82…
• Z-0502-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-82…
• Z-0503-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 32mm, B=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-82…
• Z-0504-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 22mm, B=126mm, C=96mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-96…
• Z-0505-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 24mm, B=126mm, C=96mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-24-96…
• Z-0506-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=126mm, C=96mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-96…
• Z-0507-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=126mm, C=96mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-96…
• Z-0508-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=126mm, C=96mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-96…
• Z-0509-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 32mm, B=126mm, C=96mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-96…
• Z-0510-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 22mm, B=141mm, C=111mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-1…
• Z-0511-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 24mm, B=141mm, C=111mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-24-1…
• Z-0512-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=141mm, C=111mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-1…
• Z-0513-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=141mm, C=111mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-1…
• Z-0514-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=141mm, C=111mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-1…
• Z-0515-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 32mm, B=141mm, C=111mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-1…
• Z-0516-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 22mm, B=155mm, C=125mm, D=11mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-22-1…
• Z-0518-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=155mm, C=125mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-1…
• Z-0519-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=155mm, C=125mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-1…
• Z-0520-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=155mm, C=125mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-1…
• Z-0521-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 32mm, B=155mm, C=125mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-1…
• Z-0522-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=170mm, C=140mm, D=12mm, E= 18.0f, F=.035'', G =40cm); Reorder number TFBB-26-1…
• Z-0523-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=170mm, C=140mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-1…
• Z-0524-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=170mm, C=140mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-1…
• Z-0525-05 · Terminated
  Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A=32mm, B=170mm, C=140mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-32-14…