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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Blazer Open Irrigated Ablation Catheter Material Number: M00496200, Batch: 20399570, Expiration Date: 3/13/2020 Batch: 21778776, Expiration Date: 2/21/2021 Batch: 22152470, Expiration Date: 5/21/2021 Batch: 22499259, Expiration Date: 8/13/2001 Material Number: M0049620N40 Batch::20413170, Expiration Date: 3/16/2020 Batch: 20809676, Expiration Date: 6/22/2020 Material Number: M0049620K20 Batch: 20403945, Expiration Date: 3/13/2020
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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
Product Codes/Lot Numbers:
Blazer Open Irrigated Ablation Catheter Material Number: M00496200, Batch: 20399570, Expiration Date: 3/13/2020 Batch: 21778776, Expiration Date: 2/21/2021 Batch: 22152470, Expiration Date: 5/21/2021 Batch: 22499259, Expiration Date: 8/13/2001 Material Number: M0049620N40 Batch::20413170, Expiration Date: 3/16/2020 Batch: 20809676, Expiration Date: 6/22/2020 Material Number: M0049620K20 Batch: 20403945, Expiration Date: 3/13/2020
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0699-2019
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