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Boston Scientific Corporation recalls Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a c
Recalled January 16, 2019 · FDA recall Z-0699-2019 · Boston Scientific
Hazard
Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document. · FDA Class III
Units
1,282 (all three types in Japan)
Sold at
Japan
Description
Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.
Product
Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →