Boston Scientific recalls certain Nitinol Thermocouple Electrodes due to incorrect Instructions for Use packaging. These electrodes are for RF heat lesioning of nerve tissue. Affected units have specific lot numbers and GTIN.
The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
Boston Scientific is recalling certain Nitinol Thermocouple Electrodes (TCN-10-3M) because they came with incorrect Instructions for Use. This could lead to improper use of the device for nerve tissue treatment.
The electrodes are intended for RF heat lesioning of nerve tissue. Incorrect Instructions for Use could lead to improper application, but the hazard is not described as causing serious injury in normal use.
Medical professionals using these electrodes for nerve pain treatment are most likely affected. The recall targets specific lot numbers and GTINs of the electrodes.
Check for the model TCN-10-3M with lot numbers 23049683, 23239528, or 23239529. The GTIN is 00813250017502.
Verify the Instructions for Use (IFU) included with the electrode matches the correct version for RF heat lesioning of nerve tissue.
Boston Scientific initiated a voluntary correction due to incorrect Instructions for Use being packaged with certain electrodes.
The affected model is TCN-10-3M with lot numbers 23049683, 23239528, and 23239529.
Check for the model TCN-10-3M with the specific lot numbers listed or the GTIN 00813250017502.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1695-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1695-2020 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.
