Boston Scientific recalls TCN Electrodes (TCN-5 to TCN-20 models) due to potential performance issues. Affected devices may not function as intended, but no injuries reported. Consumers should contact Boston Scientific for details.
Reusable electrodes may not meet expected performance levels.
Boston Scientific is recalling TCN Electrodes (models TCN-5 to TCN-20) because they may not meet expected performance levels. This could affect medical device function but does not indicate a risk of injury or harm.
The electrodes may not function as intended due to performance issues. This could lead to improper medical treatment but does not involve immediate safety hazards like injury or death.
Patients using Boston Scientific TCN Electrodes for medical procedures are likely affected. Those with specific model numbers listed in the recall are at risk of potential performance issues.
Check for model numbers TCN-5, TCN-10, TCN-15, TCN-20, or TCN-5-3M, TCN-10-3M, TCN-15-3M, TCN-20-3M. The product includes NITINOL material and specific dimensions.
Identify your electrode model number from the list provided in the recall notice.
Reach out to Boston Scientific for further instructions on handling the recalled product.
The recall states the electrodes may not meet expected performance levels, but no injuries have been reported. They are not considered unsafe for use.
Affected models include TCN-5, TCN-10, TCN-15, TCN-20, and their 3M cable variants.
The recall does not require stopping use; it indicates potential performance issues, not an immediate safety hazard.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2403-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2403-2026 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.