Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Reported: November 20, 2024 Initiated: October 10, 2024 #Z-0301-2025
Product Description
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 2751 units
- Distribution
- Worldwide
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110. Recalled by Boston Scientific Corporation. Units affected: 2751 units.
Why was this product recalled? ▼
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2024. Severity: Critical. Recall number: Z-0301-2025.
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