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Boston Scientific Corporation Recall 95514

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

Boston Scientific Corporation Recall 95514 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0300-2025
Event ID95514
Event DescriptionBoston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
Product TypeDevices
DistributionWorldwide
Quantity960 units
Recall ReasonBoston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Device Classification20241120
Device Code InfoGTIN 08714729992622
Center Classification Date20241112
Recall Initiation Date20241010
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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