Boston Scientific Recalls IntellaNav Ablation Catheters in Japan
Boston Scientific is recalling IntellaNav MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The source text describes the issue as slight material variations and documentation discrepancies without reporting any injuries or illnesses.
Plain-English summary
Boston Scientific Corporation is recalling 1,282 units of the IntellaNav MiFi Open-Irrigated Ablation Catheter in Japan. The recall involves three specific batches with expiration dates ranging from February 2020 to July 2021. These devices are indicated for cardiac electrophysiological mapping, diagnostic pacing, and radiofrequency ablation of specific atrial arrhythmias in patients aged 18 and older.
The recall was initiated because a supplier changed its resin sub-suppliers three times without notifying Boston Scientific. These changes resulted in slight variations in the resin material composition that were not reflected in the company's internal product documentation. The source text notes that these variations were not approved in customer documentation.
The affected devices were distributed in Japan. The source text does not report any illnesses, injuries, or deaths associated with this recall. Consumers and healthcare providers should stop using the affected catheters and contact Boston Scientific for further instructions.
The recalled product
- Product
- IntellaNav 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
- 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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