FDA Enforcement
Class I
Ongoing
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Recall: Z-0302-2025
·
Reported November 20, 2024
Enforcement
- Recall Number
- Z-0302-2025
- 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 FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
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 00191506016463
Distribution
Worldwide
Quantity
368 units