Cook brand Zenith AAA Iliac leg graft with the H&L-B… recallZ-1196-04 · 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-1196-04
- 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
- 12
- 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 18 mm - usable length 37mm - delivery system 16 FR; Catalog no. TFLE-18-37.
Code information (models, lots, serial numbers)
Lots F1571581, F1570179, F1575249, F1575334, F1575335, F1575336, F1574757, F1574758, F1574760, F1574761, F1574762 and F1574763.
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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