Z-1591-2021 Class I Ongoing
FDA device recall Z-1591-2021 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: 550 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
- 550 units
Product Description
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
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