Boston Scientific Recalls Blazer Ablation Catheters Due to Resin Changes
Boston Scientific is recalling 1,282 Blazer Open-Irrigated Ablation Catheters in Japan because resin sub-supplier changes caused material variations not reflected in internal documentation.
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 recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The source text describes documentation and material composition discrepancies without reporting any injuries or illnesses.
Plain-English summary
Boston Scientific Corporation is recalling 1,282 units of the Blazer Open-Irrigated Ablation Batch Catheter in Japan. The affected devices are indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and radiofrequency ablation of specific atrial arrhythmias in patients age 18 or older. The recall involves specific material numbers and batches with expiration dates ranging from 2020 to 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 source notes that the changes were not approved in customer documentation.
The recall is limited to the Japanese market. The source text does not report any illnesses, injuries, or deaths associated with the use of these devices. Consumers and healthcare providers in Japan should contact Boston Scientific for further instructions regarding the affected units.
The recalled product
- Product
- Blazer Open-Irrigated Ablation Batch 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
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 (9)
- Blazer Open Irrigated Ablation Catheter Material Number: M00496200
- Batch: 20399570
- Expiration Date: 3/13/2020 Batch: 21778776
- Expiration Date: 2/21/2021 Batch: 22152470
- Expiration Date: 5/21/2021 Batch: 22499259
- Expiration Date: 8/13/2001 Material Number: M0049620N40 Batch::20413170
- Expiration Date: 3/16/2020 Batch: 20809676
- Expiration Date: 6/22/2020 Material Number: M0049620K20 Batch: 20403945
- Expiration Date: 3/13/2020
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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