Zenith Alpha Abdominal Endovascular Graft (2020-06-02)
- Starting date:
- June 2, 2020
- Posting date:
- June 19, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-73357
Last updated: 2020-06-19
Affected Products
Zenith Alpha Abdominal Endovascular Graft
Reason
The affected lots 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 instructions for use.
Affected products
Zenith Alpha Abdominal Endovascular Graft
Lot or serial number
- More than 10 numbers, contact manufacturer.
Model or catalog number
- ZIMB-22-84
- ZIMB-24-70
- ZIMB-24-84
- ZIMB-24-98
- ZIMB-26-84
- ZIMB-26-98
- ZIMB-28-108
- ZIMB-28-128
- ZIMB-28-84
- ZIMB-28-98
- ZIMB-30-84
- ZIMB-30-98
- ZIMB-32-98
Companies
- Manufacturer
-
Cook Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES