Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB...
FDA Device Recall #Z-1844-2019 — Class II — April 26, 2019
Recall Summary
| Recall Number | Z-1844-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 26, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cook Inc. |
| Location | Bloomington, IN |
| Product Type | Devices |
| Quantity | 1027 |
Product Description
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32-84, ZIMB-32-98, ZIMB-36-108, ZIMB-36-118, ZIMB-36-128, ZIMB-36-70, ZIMB-36-84, ZIMB-36-98
Reason for Recall
may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in the Instructions for Use (IFU). Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention.
Distribution Pattern
No US distribution. Product distributed to the following foreign countries: Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile Columbia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Morocco, Netherlands, Norway, Poland, Portugal, Reunion, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, UK
Lot / Code Information
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9486308, 9512193, 9515073, 9522385, 9522386, 9525174, 9529028, 9561015, 9561016, 9566186, 9572281, 9575348, 9578359, 9581869, 9581870, 9584267, 9594202, 9594249, 9594250, 9609101, 9609125, 9609126, 9609127, 9611327, 9620411, 9620412, 9386604X, 9478723X 9478724, 9478725, 9522388, 9557568, 9560989, 9561017, 9566187, 9569086, 9572283, 9572284, 9575349, 9578360, 9598725, 9602900, 9602902, 9602903, 9611328, 9611329, 9611330, 9620413, 9647082, 9647083, 9650056, 9650102, 9650103, 9656968, 9656969, 9671109, 9671112 9412948, 9466894, 9522390, 9560991, 9566188, 9569087, 9611331, 9620414, 9633318, 9650104, 9650105, 9650109, 9656970, 9656971, 9671110, 9671111 9276043, 9276044, 9515075, 9522391, 9560992, 9561020, 9575350, 9611315, 9611332, 9611333, 9620415, 9625908, 9625909, 9636359, 9636360, 9650110, 9656972 9276023, 9276045, 9276298, 9276299, 9276300, 9276301, 9361560, 9386610, 9386611, 9400693, 9464262, 9464263, 9592449, 9592451, 9592452, 9592453, 9592454, 9592455, 9592456, 9592457, 9592458, 9592459, 9592460, 9592461, 9598718, 9598719, 9598720, 9598721, 9598722, 9605683, 9605684, 9605685, 9609072, 9609073, 9609074, 9609075, 9623875, 9623876, 9623877, 9623878, 9625846, 9633256, 9640512, 9671029, 9671030, 9671032, 9671033, 9386610X, 9386613 9276302, 9276303, 9276304, 9276305, 9276306, 9276307, 9365254, 9370212, 9386614, 9386615, 9386616, 9386642, 9386643, 9386645, 9415644, 9461576, 9478729, 9478730, 9486310, 9486311, 9515076, 9515078, 9515079, 9515080, 9522394, 9522395, 9522396, 9522397, 9522398, 9525176, 9525177, 9529029, 9529031, 9529032, 9529033, 9529044, 9560994, 9560995, 9561022, 9566189, 9566191, 9566192, 9566194, 9575352, 9575353, 9575354, 9575355, 9575356, 9575357, 9584268, 9598734, 9598735, 9611334, 9611335, 9611336, 9611337, 9611338, 9620416, 9623927, 9623941, 9623942, 9623943, 9623944, 9623945, 9623946, 9625910, 9629881, 9633319, 9633320, 9633321, 9633322, 9633323, 9633324, 9633325, 9636361, 9636362, 9642972, 9642973, 9642974, 9653865, 9656973, 9656974, 9656975, 9656976, 9656977, 9656991, 9664000 9376505, 9376506, 9376507, 9376580, 9376581, 9383408, 9383409, 9461581, 9522401, 9560996, 9566198, 9575358, 9575359, 9575360, 9575361, 9581871, 9581872, 9592484, 9594203, 9611340, 9611342, 9611344, 9611346, 9633326, 9633327 9376508, 9376509, 9376582, 9376583, 9560997, 9566199, 9609087, 9609102, 9609103, 9611347, 9611348, 9620380, 9623928, 9623947, 9623948, 9636363, 9636364, 9647084, 9650057, 9650058, 9653829, 9653866, 9653867, 9660202, 9664002, 9664003, 9664029, 9664030 9560998, 9566200, 9609104, 9611349, 9611350, 9623949, 9636365, 9650059, 9653868, 9664004, 9664031, 9664782 9555469, 9566201, 9569088, 9575365, 9575366, 9581873, 9623950, 9629882, 9633328, 9636366, 9642975, 9647085, 9650042, 9650046, 9650047, 9650051, 9650060, 9653869, 9653870, 9663988, 9664005, 9664032, 9664033 9365288, 9365289, 9376585, 9376586, 9376587, 9466898, 9560999, 9566206, 9575371, 9578361, 9581874, 9581875, 9598738, 9611351, 9611352, 9611353, 9611354, 9611355, 9623929, 9623951, 9623952, 9623953, 9623954, 9636367, 9640581, 9640582, 9642976, 9650106, 9650107, 9650111, 9660203, 9664006, 9664007, 9664008, 9664009, 9664034, 9664035 9365290, 9365291, 9376589, 9376590, 9380004, 9383412, 9386651, 9566153, 9566158, 9566210, 9575374, 9575376, 9575377, 9581877, 9584270, 9605692, 9605693, 9611357, 9611358, 9611359, 9611360, 9623955, 9623956, 9623957, 9623958, 9625911, 9625912, 9633329, 9633330, 9633331, 9633332, 9636368, 9636369, 9640583, 9650112, 9653871, 9653872, 9653873, 9664010, 9664011, 9664780, 9664781
Other Recalls from Cook Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0388-2022 | Class II | Flexor Check-Flo Introducer Ansel Modification ... | Nov 12, 2021 |
| Z-0387-2022 | Class II | Flexor Check-Flo Introducer Ansel Modificatio... | Nov 12, 2021 |
| Z-0414-2022 | Class II | Skinny Needle with Chiba Tip. RPN 090010, 09001... | Oct 13, 2021 |
| Z-0222-2022 | Class II | Transseptal Needle, Trocar. RPN TSNC-18-71.0, T... | Oct 8, 2021 |
| Z-0223-2022 | Class II | Transseptal Needle with Catheter. RPN TSN-17-75... | Oct 8, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.