Reported Jan 16, 2019 · Ongoing
IntellaTip 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?
- IntellaTip 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
- IntellaTip MiFi Open-Irrigated
- Ablation Catheter Material NumberM004PM96200
- Batch20368736
- Expiration Date3/5/2020
- Batch20531648
- Expiration Date4/16/2020
- Batch20560477
- Expiration Date4/23/2020
- Batch20566637
- Expiration Date4/24/2020
- Batch20628704
- Expiration Date5/9/2020
- Batch20628705
- Expiration Date5/10/2020
- Batch20763900
- Expiration Date6/12/2020
- Batch20769113
- Expiration Date6/13/2020
- Batch21318000
- Expiration Date10/29/2020
- Batch21318001
- Expiration Date10/29/2020
- Batch21357647
- Expiration Date11/10/2020
- Batch21463186
- Expiration Date12/3/2020
- Batch21543193
- Expiration Date12/20/2020
- Batch21574774
- Expiration Date1/4/2021
- Batch22195929
- Expiration Date5/31/2021
- Batch22202991
- Expiration Date6/3/2021
- Batch22290601
- Expiration Date6/3/2021
- Batch22305067
- Expiration Date6/25/2021
- Batch22315782
- Expiration Date6/27/2021
- Batch22317356
- Expiration Date6/28/2021
- Batch22327178
- Expiration Date7/1/2021
- Batch22329367
- Expiration Date7/2/2021
- Batch22330626
- Expiration Date7/2/2021
- Batch22371866
- Expiration Date7/12/2021
- Batch22371868
- Expiration Date7/12/2021
- Batch22379905
- Expiration Date7/15/2021
- Batch22435929
- Expiration Date7/26/2021
- Batch22435930
- Expiration Date7/26/2021
- Batch22438118
- Expiration Date7/27/2021
- Batch22455198
- Expiration Date7/31/2021
- Batch22499957
- Expiration Date8/10/2021
- Material NumberM004PM9620K20
- Batch20371559
- Expiration Date3/6/2020
- Batch20542305
- Expiration Date4/18/2020
- Batch20548241
- Expiration Date4/19/2020
- Batch20639975
- Expiration Date5/14/2020
- Batch20677314
- Expiration Date5/21/2020
- Batch20772834
- Expiration Date6/14/2020
- Batch22321772
- Expiration Date6/29/2021
- Batch22326857
- Expiration Date7/1/2021
- Material NumberM004PM9620N40
- Batch20371742
- Expiration Date3/8/2020
- Batch20463744
- Expiration Date3/28/2020
- Batch20622763
- Expiration Date5/8/2020
- Batch20775597
- Expiration Date6/14/2020
- Batch22340824
- Expiration Date7/4/2021
- Batch22371871
- Expiration Date7/12/2021
- Batch22374909
- Expiration Date7/13/2021
- 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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