Z-0302-2025 Class I Ongoing
FDA device recall Z-0302-2025 was initiated by Boston Scientific Corporation on October 10, 2024 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 368 units.
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
- 368 units
Product Description
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
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 00191506016463