Unify and Fortify cardiac devices recall in Canada: battery performance alert
In plain language
This recall involves several models of Unify and Fortify cardiac devices sold in Canada. It is being recalled to provide a firmware upgrade that improves battery performance detection. Patients should consult with their healthcare provider regarding this upgrade.
What to do
- Stop using the product immediately.
- Check model/serial numbers if provided.
- Return, repair, or dispose of it as instructed.
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Affected products
Unify
Model: CD3235-40, CD3235-40Q
Lot: All lots.
Fortify VR
Model: CD1233-40, CD1233-40Q
Lot: All lots.
Fortify DR
Model: CD2233-40, CD2233-40Q
Lot: All lots.
Fortify ST VR
Model: CD1235-40, CD1235-40Q
Lot: All lots.
Fortify ST DR
Model: CD2235-40, CD2235-40Q
Lot: All lots.
Unify Quadra Cardiac Resynchronization Device, Tiered-therapy Cardioverter/Defibrillator
Model: CD3251-40, CD3251-40Q
Lot: All lots.
Fortify Assura DR
Model: CD2259-40, CD2259-40Q, CD2359-40C, CD2359-40QC
Lot: All lots.
Fortify Assura VR
Model: CD1259-40, CD1259-40Q, CD1359-40C, CD1359-40QC
Lot: All lots.
Unify Assura
Model: CD3261-40, CD3261-40Q, CD3361-40C, CD3361-40QC
Lot: All lots.
Quadra Assura
Model: CD3367-40, CD3367-40C, CD3367-40Q, CD3367-40QC
Lot: All lots.
Quadra Assura MP
Model: CD3371-40C, CD3371-40QC
Lot: All lots.
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: All lots.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: CD1233-40, CD1233-40Q, CD1235-40, CD1235-40Q, CD1259-40, CD1259-40Q, CD1359-40C, CD1359-40QC, CD2233-40, CD2233-40Q, CD2235-40, CD2235-40Q, CD2259-40, CD2259-40Q, CD2359-40C, CD2359-40QC, CD3235-40, CD3235-40Q, CD3251-40, CD3251-40Q, CD3261-40, CD3261-40Q, CD3361-40C, CD3361-40QC, CD3367-40, CD3367-40C, CD3367-40Q, CD3367-40QC, CD3371-40C, CD3371-40QC
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?
This recall involves several models of Unify and Fortify cardiac devices sold in Canada. It is being recalled to provide a firmware upgrade that improves battery performance detection. Patients should consult with their healthcare provider regarding this upgrade.
What should consumers do?
Stop using the product immediately. Check model/serial numbers if provided. Return, repair, or dispose of it as instructed.
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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on June 22, 2018.
Is the Unify, Fortify brand affected by this recall?
Yes, Unify, Fortify products are affected by this recall. This recall involves several models of Unify and Fortify cardiac devices sold in Canada. It is being recalled to provide a firmware upgrade that improves battery performance detection. Patients should consult with their healthcare provider regarding this upgrade.