Reported Jan 16, 2019 · Ongoing
Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a…
Boston Scientific Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 300 Boston Scientific Way · Marlborough, MA · 01752-1291
Is this the product you have?
- Blazer Open-Irrigated
- Ablation Batch Catheter Product UsageOpen Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump
- are indicated forCardiac 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
- Lot codes and dates
- Blazer Open Irrigated
- Ablation Catheter Material NumberM00496200
- Batch20399570
- Expiration Date3/13/2020
- Batch21778776
- Expiration Date2/21/2021
- Batch22152470
- Expiration Date5/21/2021
- Batch22499259
- Expiration Date8/13/2001
- Material NumberM0049620N40
- Batch:20413170
- Expiration Date3/16/2020
- Batch20809676
- Expiration Date6/22/2020
- Material NumberM0049620K20
- Batch20403945
- Expiration Date3/13/2020
- Amount recalled
- 1,282 (all three types in Japan)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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