Cook brand Zenith AAA Iliac leg graft with the H&L-B… recallZ-1213-04 · Cook, Inc. · initiated Jun 10, 2004
Terminated All recalls posted in July 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cook, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
FDA root cause category: Other
What the company is doing
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
Recall details
- Recall number
- Z-1213-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 10, 2004
- Posted by the FDA
- Jul 27, 2004
- Recalling firm
- Cook, Inc.
- Quantity
- 2
- Product code
- MIH
- FDA submissions
- P020018
- Distribution
- Nationwide, Canada, Denmark and Japan.
Product description
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 8 mm - usable length 88mm - delivery system 14 FR; Catalog no. TFLE-8-88.
Code information (models, lots, serial numbers)
Lots F1566718 and F1566719.
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 G32551William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT5 deaths44 reports
- Zenith G32543William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT6 deaths18 reports
- Zenith G32554William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 deaths17 reports
- Zenith G32542William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death15 reports
- Zenith G32539William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT14 reports
- Zenith G32537William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death13 reports
- Zenith G32538William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT4 deaths13 reports
- Zenith G32544William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 deaths9 reports
- Zenith G32533William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death8 reports
- Zenith G32532William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT7 reports
- Zenith G32550William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 deaths7 reports
- Zenith G32534William A. Cook Australia Pty. Ltd. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 deaths6 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 29300).
- Z-1160-04 · TerminatedCook brand Zenith AAA Converter with the H&L-B One-Shot Introducer System, preloaded converter - proximal diameter 24 mm - distal diameter 12 mm - length 80 mm; Reorder no. ESC-24-…
- Z-1161-04 · TerminatedCook brand Zenith AAA Endovascular Graft Iliac Leg Extensions - diameter 14 mm - length 55 mm -introducer sheath size 14 FR; Reorder no. ESLE-14-55-TAG.
- Z-1162-04 · TerminatedCook brand Reorder # PLVTW-14.0-38-30-BNS. Silhouette Transitionless Peel-Away Introducer
- Z-1163-04 · TerminatedCook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 22 mm - iliac leg diameters…
- Z-1164-04 · TerminatedCook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 22 mm - iliac leg diameters…
- Z-1165-04 · TerminatedCook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 22 mm - iliac leg diameters…
- Z-1166-04 · TerminatedCook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters…
- Z-1167-04 · TerminatedCook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters…
- Z-1168-04 · TerminatedCook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters…
- Z-1169-04 · TerminatedCook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters…
- Z-1170-04 · TerminatedCook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters…
- Z-1171-04 · TerminatedCook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters…
- Z-1172-04 · TerminatedCook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters…
- Z-1173-04 · TerminatedCook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters…
- Z-1174-04 · TerminatedCook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters…
- Z-1175-04 · TerminatedCook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 26 mm - iliac leg diameters…
- Z-1176-04 · TerminatedCook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 10 mm - usable length 105mm - delivery system 14 F…
- Z-1177-04 · TerminatedCook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 10 mm - usable length 122mm - delivery system 14 F…
- Z-1178-04 · TerminatedCook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 10 mm - usable length 37mm - delivery system 14 FR…
- Z-1179-04 · TerminatedCook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 10 mm - usable length 54mm - delivery system 14 FR…
- Z-1180-04 · TerminatedCook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 10 mm - usable length 71mm - delivery system 14 FR…
- Z-1181-04 · TerminatedCook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 10 mm - usable length 88mm - delivery system 14 FR…
- Z-1182-04 · TerminatedCook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 12 mm - usable length 105mm - delivery system 14 F…
- Z-1183-04 · TerminatedCook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 12 mm - usable length 122mm - delivery system 14 F…
- Z-1184-04 · TerminatedCook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 12 mm - usable length 37mm - delivery system 14 FR…
- Z-1185-04 · TerminatedCook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 12 mm - usable length 54mm - delivery system 14 FR…
- Z-1186-04 · TerminatedCook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 12 mm - usable length 71mm - delivery system 14 FR…
- Z-1187-04 · TerminatedCook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 12 mm - usable length 88mm - delivery system 14 FR…
- Z-1188-04 · TerminatedCook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 14 mm - usable length 37mm - delivery system 14 FR…
- Z-1189-04 · TerminatedCook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 14mm - usable length 54mm - delivery system 14 FR;…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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