EXCOR Pediatric Ventricular Assist Device System - Blood Pumps and EXCOR System - Blood Pump PU Valves (2018-05-18)
In plain language
This recall involves EXCOR Pediatric Ventricular Assist Device System blood pumps and EXCOR System - Blood Pump PU Valves sold in Canada. They are being recalled because of issues with the membrane layers separating air and blood chambers. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers if provided.
- Return the product as instructed.
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Affected products
EXCOR Pediatric Ventricular Assist Device System blood pumps
Model: P10P-001, P25P-001X01, P30P-001X01, P50P-001, P60P-001
Lot: All lots
EXCOR System - Blood Pump PU Valves
Why this matters
Device malfunction
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: P10P-001, P25P-001X01, P30P-001X01, P50P-001, P60P-001
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?
Device malfunction
What should consumers do?
Stop using the product immediately. Check model numbers if provided. Return the product 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?
Yes, there may be a health risk. Device malfunction
When was this product recalled?
This product was recalled on June 22, 2018.
Is the EXCOR brand affected by this recall?
Yes, EXCOR products are affected by this recall. This recall involves EXCOR Pediatric Ventricular Assist Device System blood pumps and EXCOR System - Blood Pump PU Valves sold in Canada. They are being recalled because of issues with the membrane layers separating air and blood chambers. Stop using the product and follow the return steps in the official notice.