Cardiosave System recall in Canada: Performance issue
In plain language
This recall involves the Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump sold in Canada. It's being recalled because it may unexpectedly shut down during use. 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 more information.
- Follow the manufacturer's instructions for return or repair.
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Affected products
Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump
Model: 0998-00-0800-XX
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Unexpected shutdown during use
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?
Unexpected shutdown during use
What should consumers do?
Stop using the product immediately. Contact the manufacturer for more information. Follow the manufacturer's instructions for return or repair.
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. Unexpected shutdown during use
When was this product recalled?
This product was recalled on January 4, 2023.
Is the Datascope Corp. brand affected by this recall?
Yes, Datascope Corp. products are affected by this recall. This recall involves the Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump sold in Canada. It's being recalled because it may unexpectedly shut down during use. Stop using the product and follow the return/repair steps in the official notice.