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 involves a medical device used in cardiac ablation procedures that was not manufactured to specification. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and the agency classification is Class II without specific hospitalization reports.
Plain-English summary
Boston Scientific Corporation is recalling 968 units of IntellaTip MiFi XP Temperature Ablation Catheters, specifically the 10m x 8F (2.67mm) Large Curve model. The recall covers units with Catalog Number PM4790K2 and Material Number M004PM47900K2, with serial numbers ranging from 16739673 to 16872935 and expiry dates between May 11, 2014, and January 13, 2017.
The recall was initiated because some units were not manufactured according to specification. The source text does not specify the exact nature of the manufacturing deviation or report any associated injuries or illnesses. The BSC Controller and Accessories are indicated for use in conjunction with these catheters for cardiac ablation procedures.
The affected products were distributed nationwide. Healthcare providers and facilities should stop using the affected catheters and contact Boston Scientific Corporation for further instructions on returns or replacements.
The recalled product
- Product
- IntellaTip MiFi XP Temperature Ablation Catheter; 10m 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.
- 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 (14)
- Catalog Number: PM4790K2
- Material Number: M004PM47900K2
- Serial numbers: 16739673
- 16739674
- 16739675
- 16739676
- 16739677
- 16739678
- 16739679
- 16739860
- 16872121
- 16872935 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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