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 specific hazards beyond non-compliance with manufacturing specifications, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Boston Scientific Corporation is recalling 968 units of the IntellaTip MiFi XP Temperature Ablation Catheter, 10m x 8F (2.67mm) Asymmetric Curve. The recall affects catalog number PM4790N4 and material number M004PM47900N4, with serial numbers 16743269 and 16872007. The affected units have expiry dates ranging from May 11, 2014, to January 13, 2017.
The recall was initiated because some units of the 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 providers and facilities should stop using the affected units and contact Boston Scientific for further instructions.
The recalled product
- Product
- IntellaTip MiFi XP Temperature Ablation Catheter; 10m 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 (7)
- Catalog Number: PM4790N4
- Material Number: M004PM47900N4
- Serial numbers: 16743269
- 16872007
- 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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