Zenith Alpha Abdominal Endovascular Graft (2019-04-25)
In plain language
This recall involves specific lots of the Zenith Alpha Abdominal Endovascular Graft sold in Canada. It's being recalled because a damaged safety lock knob could prevent the graft from deploying properly. Devices already implanted are not affected by this recall.
What to do
- Stop using the product immediately.
- Check model and lot numbers if you have this product.
- Contact Cook (Canada) Inc. for more information.
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Affected products
Zenith Alpha Abdominal Endovascular Graft
Model: 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
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Difficulty deploying medical device
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 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
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Difficulty deploying medical device
What should consumers do?
Stop using the product immediately. Check model and lot numbers if you have this product. Contact Cook (Canada) Inc. for more information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Difficulty deploying medical device
When was this product recalled?
This product was recalled on April 30, 2019.
Is the Zenith Alpha brand affected by this recall?
Yes, Zenith Alpha products are affected by this recall. This recall involves specific lots of the Zenith Alpha Abdominal Endovascular Graft sold in Canada. It's being recalled because a damaged safety lock knob could prevent the graft from deploying properly. Devices already implanted are not affected by this recall.