Z-0300-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2024
- Initiation Date
- October 10, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 960 units
Product Description
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
Reason for Recall
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Distribution Pattern
Worldwide
Code Information
GTIN 08714729992622