FDA Device Recall Z-0300-2025

Boston Scientific Corporation · Saint Paul, MN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060

Lot / serial / GTIN: GTIN 08714729992622

Quantity: 960 units

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.

Recall record

Recall number: Z-0300-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide
Recall initiated: 2024-10-10
Classified by FDA Center: 2024-11-12
FDA published: 2024-11-20
Recalling firm: Boston Scientific Corporation
Firm location: Saint Paul, MN

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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