FDA Enforcement
Class I
Ongoing
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
Recall: Z-0297-2025
·
Reported November 20, 2024
Enforcement
- Recall Number
- Z-0297-2025
- Event ID
- 95514
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 20, 2024
- Initiation Date
- October 10, 2024
- Classification Date
- November 12, 2024
- Address
- 4100 Hamline Ave N, N/A, Saint Paul, MN, 55112-5700, United States
Description
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
Reason
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Code Info
GTIN 08714729992561
Distribution
Worldwide
Quantity
4422 units