Boston Scientific Corporation: Medical Device Recall in 2024 - (Recall #: Z-0301-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110

Product Classification:

Class I

Date Initiated: October 10, 2024

Date Posted: November 20, 2024

Recall Number: Z-0301-2025

Event ID: 95514

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.

Status: Ongoing

Product Quantity: 2751 units

Code Information:

GTIN00191506016456

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated