Intra-Aortic Balloon Catheters recall in Canada: endotoxin contamination
In plain language
This recall involves certain Intra-Aortic Balloon Catheters sold in Canada. They are being recalled because some units may have elevated endotoxin contamination. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Contact Datascope Corp. for more information.
- Follow the manufacturer's instructions for return or disposal.
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Affected products
LINEAR INTRA-AORTIC BALLOON CATHETER WITH INSERTION KIT
Model: 0684-00-0478-01, 0684-00-0478-02, 0684-00-0479-01, 0684-00-0479-02, 0684-00-0480-01, 0684-00-0480-02
Lot: More than 10 numbers, contact manufacturer.
SENSATION INTRA-AORTIC BALLOON CATHETER DATASCOPE EXTEND. W/INS. KIT/INTRO.
Model: 0684-00-0469-01, 0684-00-0470-01
Lot: More than 10 numbers, contact manufacturer.
MEGA 8FR. INTRA-AORTIC BALLOON CATHETER
Model: 0684-00-0296-01
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Endotoxin contamination
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: 0684-00-0296-01, 0684-00-0469-01, 0684-00-0470-01, 0684-00-0478-01, 0684-00-0478-02, 0684-00-0479-01, 0684-00-0479-02, 0684-00-0480-01, 0684-00-0480-02
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?
Endotoxin contamination
What should consumers do?
Stop using the product immediately. Contact Datascope Corp. for more information. Follow the manufacturer's instructions for return or disposal.
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. Endotoxin contamination
When was this product recalled?
This product was recalled on September 11, 2020.