Reported Jan 16, 2019 · Ongoing
IntellaNav MiFi Open-Irrigated Ablation 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?
- IntellaNav MiFi Open-Irrigated
- Ablation 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
- IntellaNav Open-Irrigated
- Ablation Catheter Material NumberM004R96200
- Batch22208397
- Expiration Date6/4/2021
- Batch22389516
- Expiration Date7/16/2021
- Batch22525798
- Expiration Date2/14/2020
- 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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