FDA recall Z-0297-2025

Product

Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.

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

Worldwide

Key facts

Status

Ongoing

Initiation date

2024-10-10

Report date

2024-11-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0297-2025