Zenith Alpha Abdominal Endovascular Graft (2020-08-11)
- Starting date:
- August 11, 2020
- Posting date:
- August 28, 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-73791
Last updated:
2020-08-28
Affected Products
Zenith Alpha Abdominal Endovascular Graft
Reason
William Cook Europe ApS is voluntarily recalling specific lots of the Zenith AlphaTM Abdominal Endovascular Graft. The affected lots may contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or troubleshooting deployment 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
Multiple lots, contact manufacturer.
Companies
- Manufacturer
-
William Cook Europe APS
Sandet 6
Bjaeverskov
4632
DENMARK