Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters
Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device used in cardiac ablation procedures. While no specific injuries are reported in the text, the risk of harm from a device not meeting specifications in a high-risk procedure places it in the High severity category.
Plain-English summary
Boston Scientific Corporation is recalling 968 units of IntellaTip MiFi XP Temperature Ablation Catheters, specifically the 8mm x 8F (2.67mm) Asymmetric Curve model. The recall covers units with Catalog Number PM4500N4 and Material Number M004PM45000N40. The affected serial numbers are 16521557, 16615976, 16623754, 16623755, 16736927, 16739588, 16743271, and 16872124, with expiry dates ranging from May 11, 2014, to January 13, 2017.
The recall was initiated because some units were not manufactured according to specification. The FDA has classified this as a Class II recall. The BSC Controller and Accessories associated with these catheters are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
The affected products were distributed nationwide. Healthcare facilities and consumers should check their inventory for the specific serial numbers and catalog numbers listed above. If you have these products, you should stop using them and contact Boston Scientific Corporation for further instructions on return or replacement.
The recalled product
- Product
- IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 968
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Catalog Number: PM4500N4
- Material Number: M004PM45000N40
- Serial numbers: 16521557
- 16615976
- 16623754
- 16623755
- 16736927
- 16739588
- 16743271
- 16872124. Expiry Dates: May 11
- 2014 to January 13
- 2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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