Z-1592-2021 Class I Ongoing
FDA device recall Z-1592-2021 was initiated by Boston Scientific Corporation on April 12, 2021 and is designated Class I. Reason for recall: The firm has received reports of stent migration after implantation The recall status is ongoing. Affected quantity: 34,248 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 26, 2021
- Initiation Date
- April 12, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34,248 units
Product Description
VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Reason for Recall
The firm has received reports of stent migration after implantation
Distribution Pattern
Worldwide - US Nationwide Distribution
Code Information
all batches/lots of the device manufactured between May 2018 through April 2021