Ultra Intra-Aortic Balloon Pumps recall in Canada: performance issue
In plain language
This recall involves Ultra Intra-Aortic Balloon Pumps (IABP) sold in Canada. They are being recalled because of a performance issue that could lead to serious health consequences. Stop using the product and contact the manufacturer for more information.
What to do
- Stop using the product immediately.
- Contact the manufacturer for additional information.
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Affected products
Ultra 8® Intra-Aortic Balloon - Lightwave Sensor
Model: IAB-05830-LWS, IAB-05840-LWS
Lot: More than 10 numbers, contact manufacturer.
UltraFLEX™ Intra-Aortic Balloon
Model: IAB-06830-U, IAB-06840-U
Lot: More than 10 numbers, contact manufacturer.
Ultra IABP Catheter Kit
Model: IAB-05830-U, IAB-05840-U
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Serious health consequences due to performance issue
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: IAB-05830-LWS, IAB-05830-U, IAB-05840-LWS, IAB-05840-U, IAB-06830-U, IAB-06840-U
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?
Serious health consequences due to performance issue
What should consumers do?
Stop using the product immediately. Contact the manufacturer for additional 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. Serious health consequences due to performance issue
When was this product recalled?
This product was recalled on May 7, 2024.
Is the Arrow International Llc Subsidiary Of Teleflex Incorporated brand affected by this recall?
Yes, Arrow International Llc Subsidiary Of Teleflex Incorporated products are affected by this recall. This recall involves Ultra Intra-Aortic Balloon Pumps (IABP) sold in Canada. They are being recalled because of a performance issue that could lead to serious health consequences. Stop using the product and contact the manufacturer for more information.