Boston Scientific recalls certain Nitinol Thermocouple Electrodes (TCN-10) due to incorrect Instructions for Use (IFU) packaging. Affected units have specific lot numbers and GTIN. Consumers should contact the company for correction.
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 specific Nitinol Thermocouple Electrodes (TCN-10) because the packaging includes incorrect Instructions for Use. This could lead to improper use of the device in medical procedures.
The incorrect Instructions for Use (IFU) could lead to improper application of the electrode during medical procedures. However, the hazard is not described as causing immediate injury or death.
Medical professionals using the TCN-10 electrodes for pain treatment may be affected. Patients using these electrodes under medical supervision are not at risk.
Check for the model TCN-10 with lot numbers: 23045871, 23049691, 23049693, 23049695, 23131523, 23131525, 23155050, 23155052, 23176308, 23213325, 23213326, 23235460, or 23235463. The GTIN is 00813250013054.
Reach out to Boston Scientific to get the correct Instructions for Use for your specific electrode model.
The Boston Scientific Nitinol Thermocouple Electrode (TCN-10) with specific lot numbers and GTIN 00813250013054.
The packaging includes incorrect Instructions for Use (IFU) for the electrode, which could lead to improper medical application.
No, the recall does not require stopping use immediately. The hazard is low risk and the remedy is to contact Boston Scientific for corrected instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1694-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1694-2020 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.
