Boston Scientific Corporation: Medical Device Recall in 2024 - (Recall #: Z-0302-2025)

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 US, Material Number M004CRBS2160

Product Classification:

Class I

Date Initiated: October 10, 2024

Date Posted: November 20, 2024

Recall Number: Z-0302-2025

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: 368 units

Code Information:

GTIN 00191506016463

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated