Cook Zenith Alpha Abdominal Endovascular Graft Recalled for Excess Glue
Cook Inc. is recalling Zenith Alpha Abdominal Endovascular Grafts due to excess glue in the delivery system handle, which may prevent full deployment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device that may fail to deploy as intended, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Cook Inc. is recalling 684 units of the Zenith Alpha Abdominal Endovascular Graft. The product is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms. The recall is limited to units distributed outside the United States, including Canada, various European countries, and locations in Asia and the Middle East.
The recall was initiated because the delivery system handle may contain excess glue. This defect can result in an inability to fully deploy the graft using the standard method or the troubleshooting deployment method provided in the Instructions for Use (IFU). The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare providers and patients who have received this device should contact Cook Inc. for further instructions on how to proceed. The recall covers specific Reference Part Numbers and Lot Numbers listed in the official FDA record Z-2964-2020.
The recalled product
- Product
- Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-
- Manufacturer
- Cook Inc.
- Affected units
- 684
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Reference Part / Lot Numbers : ZIMB-22-108 9182141
- 9983461
- 10010790
- 10136649
- 13023971
- ZIMB-22-118 10077065
- ZIMB-22-70 9170948
- 9196501
- 9196502
- 9311502
- 9415647
- 10156546
- 10275239
- 10337923
- ZIMB-22-84 9100087
- 9100089
- 9118160
- 9124830
- 9132423
- 9182145
Distribution
Distribution scope not specified by the agency.
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