CARDIOSAVE Intra-Aortic Balloon Pump recall in Canada: therapy interruption risk
In plain language
This recall involves the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) sold in Canada. It's being recalled because fluid ingress can affect electronic circuit boards, which may prevent the device from starting or continuing therapy. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Contact the manufacturer for return or repair instructions.
- Check model numbers if provided.
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Affected products
Intra-Aortic Balloon Pump (IABP)
Model: 0998-00-0800-XX
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Therapy interruption risk
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: 0998-00-0800-XX
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?
Therapy interruption risk
What should consumers do?
Stop using the product immediately. Contact the manufacturer for return or repair instructions. Check model numbers if provided.
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. Therapy interruption risk
When was this product recalled?
This product was recalled on May 25, 2018.
Is the CARDIOSAVE brand affected by this recall?
Yes, CARDIOSAVE products are affected by this recall. This recall involves the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) sold in Canada. It's being recalled because fluid ingress can affect electronic circuit boards, which may prevent the device from starting or continuing therapy. Stop using the product and follow the return/repair steps in the official notice.