Recall Z-2546-2020— Cook Inc.
Class II · Terminated
Class II FDA medical device recall by Cook Inc., initiated 2020-06-02, terminated 2022-05-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair.. Reason: Identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standard method provided in the IFU..
- Recalling firm
- Cook Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-02
- Terminated
- 2022-05-05
- Firm location
- Bloomington, IN, United States
Product description
Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair.
Reason for recall
Identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standard method provided in the IFU.
Data sourced from openFDA. This site is unofficial and independent of the FDA.