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 3/5 (High).
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. The hazard is a manufacturing deviation from specification, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling 968 units of IntellaTip MiFi XP Temperature Ablation Catheters, 8mm x 8F (2.67mm) Standard Curve. The recall covers all models with catalog number PM4500 and material number M004PM45000. The affected serial numbers are 16521554, 16538010, 16573561, 16615973, 16744972, 16744973, 16744974, 16744975, 16872127, and 16872836. The expiry dates for these units range from May 7, 2014, to January 13, 2017.
The recall was initiated because some units of the IntellaTip MiFi XP Temperature Ablation Catheters were not manufactured according to specification. The BSC Controller and Accessories 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 the product is found, it should be removed from use and returned to Boston Scientific Corporation according to their instructions.
The recalled product
- Product
- IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard 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: PM4500
- Material Number: M004PM45000
- Serial numbers: 16521554
- 16538010
- 16573561
- 16615973
- 16744972
- 16744973
- 16744974
- 16744975
- 16872127
- 16872836. Expiry Dates: May 7
- 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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