Boston Scientific Recalls IntellaTip MiFi Ablation Catheters in Japan
Boston Scientific is recalling 1,282 IntellaTip MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Boston Scientific Corporation is recalling 1,282 units of the IntellaTip MiFi Open-Irrigated Ablation Catheter in Japan. The recall involves three specific material numbers: M004PM96200, M004PM9620K20, and M004PM9620N40. The affected batches have expiration dates ranging from March 2020 to July 2021.
The recall was initiated because the supplier changed its resin sub-suppliers three times without notifying Boston Scientific. These changes resulted in slight variations in the resin material compositions that were not reflected in Boston Scientific's internal product documentation. The variations were not approved in customer documentation.
The IntellaTip MiFi Open-Irrigated Ablation Catheter is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and radiofrequency ablation of specific atrial arrhythmias in patients age 18 years or older. The recall is classified as Class III by the FDA, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli…
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 1,282
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 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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