Recall Z-0699-2019— Boston Scientific Corporation
Class III · Ongoing
Class III FDA medical device recall by Boston Scientific Corporation, initiated 2018-11-28. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2018-11-28
- Firm location
- Marlborough, MA, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.