Zenith Alpha Abdominal Endovascular Graft (2019-04-25)
- Starting date:
- April 25, 2019
- Posting date:
- April 30, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-69792
Last updated: 2019-04-30
Affected Products
Zenith Alpha Abdominal Endovascular Graft
Reason
Cook (Canada) Inc. has learned from one of their manufacturers, William Cook Europe, that specific lots of the Zenith Alpha Abdominal Endovascular Graft may contain a damaged grey 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 instruction for use (IFU).
Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention.
Devices already implanted are not affected by this recall.
Affected products
Zenith Alpha Abdominal Endovascular Graft
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- ZIMB-22-108
- ZIMB-22-70
- ZIMB-22-84
- ZIMB-22-98
- ZIMB-24-70
- ZIMB-24-84
- ZIMB-26-108
- 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-30-84
- ZIMB-30-98
- ZIMB-32-108
- ZIMB-32-84
- ZIMB-32-98
- ZIMB-36-70
Companies
- Manufacturer
-
William Cook Europe APS
Sandet 6
Bjaeverskov
4632
DENMARK