Palmaz Genesis Biliary Stent recall in Canada: performance issue
In plain language
This recall involves the Palmaz Genesis Biliary Stent/Opta Pro .035" Delivery System. It's being recalled because of a performance issue that may cause the stent to dislodge. Healthcare professionals should contact the manufacturer for more information.
What to do
- Contact the manufacturer if you require additional information.
- Check model and lot numbers if you have this product.
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Affected products
Palmaz Genesis Biliary Stent/Opta Pro .035" Delivery System - 80cm Shaft
Model: PG2990BPS, PG3990BPS
Lot: 82180267, 82206059, 82208532, 82191527, 82193089, 82184806, 82191321
Palmaz Genesis Biliary Stent/Opta Pro .035" Delivery System - 135cm Shaft
Model: PG2990BPX, PG3990BPX
Lot: 82185924, 82208528, 82208524, 82211296
Why this matters
Stent dislodgement
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: 82180267, 82206059, 82208532, 82191527, 82193089, 82184806, 82191321, 82185924, 82208528, 82208524, 82211296
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX
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?
Stent dislodgement
What should consumers do?
Contact the manufacturer if you require additional information. Check model and lot numbers if you have this product.
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. Stent dislodgement
When was this product recalled?
This product was recalled on June 7, 2022.
Is the Cordis Cashel brand affected by this recall?
Yes, Cordis Cashel products are affected by this recall. This recall involves the Palmaz Genesis Biliary Stent/Opta Pro .035" Delivery System. It's being recalled because of a performance issue that may cause the stent to dislodge. Healthcare professionals should contact the manufacturer for more information.