Reported Jun 25, 2014 · Terminated
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 · 47215 Lakeview Blvd · Fremont, CA · 94538-6530
Is this the product you have?
- IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
- Lot codes and dates
- Catalog NumberPM4500K2
- Material NumberM004PM45000K20
- Serial numbers
165604061656040816573562165735631657356416599366166061481661597416615975166237561674327416743275167432761675763216757633167576341675763516757636167576371675763816757639167577811675778216872835
- Expiry Dates
May 112014 to January 132017
- Amount recalled
- 968 units total all models
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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