Recall Z-1591-2021
Boston Scientific Corporation · initiated April 12, 2021
Class I – dangerous or defective products that could cause serious health problems or death
Product
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
Codes / lots: all batches/lots of the device manufactured between May 2018 through April 2021
Reason for recall
The firm has received reports of stent migration after implantation
FDA-determined cause: Under Investigation by firm
Action taken
Boston Scientific initiated the recall by letter on April 12, 2021. The letter requested the consignee cease use and further distribution of the affected product, segregate and return to Boston Scientific. Distributors were directed to further distribute the notice to their customers. For questions contact your local Sales Representative.
Details
- Recall number
- Z-1591-2021
- Initiated
- April 12, 2021
- Product code
- QAN – Stent, Iliac Vein
- Quantity
- 550 units
- Distribution
- Worldwide - US Nationwide Distribution
- Recalling firm
- Boston Scientific Corporation, Maple Grove, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1592-2021 Class I | VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter…The firm has received reports of stent migration after implantation | 04/12/2021Open, Classified |