Emerge Monorail PTCA Dilatation Catheter recall in Canada: manufacturing defect
In plain language
This recall involves Emerge Monorail PTCA Dilatation Catheter and NC Emerge PTCA Dilatation Catheter sold in Canada. They are being recalled because specific batches may be missing a hydrophilic coating. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check the lot or serial numbers and model or catalog numbers.
- Contact Boston Scientific Corporation for return instructions.
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Affected products
Emerge Monorail PTCA Dilatation Catheter
Model: H7493918912300, H7493918915150, H7493918915300, H7493918915350, H7493919315200, H7493919315250
Lot: 20909603, 21363021, 22619082, 23181062, 23901505, 23924000
NC Emerge PTCA Dilatation Catheter
Model: H7493926712250, H7493926715350
Lot: 23541260, 23998683
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: 20909603, 21363021, 22619082, 23181062, 23901505, 23924000, 23541260, 23998683
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: H7493918912300, H7493918915150, H7493918915300, H7493918915350, H7493919315200, H7493919315250, H7493926712250, H7493926715350
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?
This recall involves Emerge Monorail PTCA Dilatation Catheter and NC Emerge PTCA Dilatation Catheter sold in Canada. They are being recalled because specific batches may be missing a hydrophilic coating. Stop using the product and follow the return steps in the official notice.
What should consumers do?
Stop using the product immediately. Check the lot or serial numbers and model or catalog numbers. Contact Boston Scientific Corporation for return instructions.
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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on November 22, 2019.
Is the Emerge brand affected by this recall?
Yes, Emerge products are affected by this recall. This recall involves Emerge Monorail PTCA Dilatation Catheter and NC Emerge PTCA Dilatation Catheter sold in Canada. They are being recalled because specific batches may be missing a hydrophilic coating. Stop using the product and follow the return steps in the official notice.