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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Boston Scientific Corporation is recalling 968 units of IntellaTip MiFi XP Temperature Ablation Catheters, specifically the 8mm x 8F (2.67mm) Large Curve model. The recall is being conducted because some of these units were not manufactured according to specification.
The affected devices are identified by Catalog Number PM4500K2 and Material Number M004PM45000K20. The recall includes specific serial numbers ranging from 16560406 to 16872835, with expiry dates between May 11, 2014, and January 13, 2017. The devices were distributed nationwide.
Healthcare providers should stop using the affected catheters and contact Boston Scientific Corporation for further instructions. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures, but this recall specifically targets the IntellaTip MiFi XP Temperature Ablation Catheter units that failed to meet manufacturing specifications.
The recalled product
- Product
- 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.
- 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 (20)
- Catalog Number: PM4500K2
- Material Number: M004PM45000K20
- Serial numbers: 16560406
- 16560408
- 16573562
- 16573563
- 16573564
- 16599366
- 16606148
- 16615974
- 16615975
- 16623756
- 16743274
- 16743275
- 16743276
- 16757632
- 16757633
- 16757634
- 16757635
- 16757636
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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