Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions
Boston Scientific is voluntarily correcting 40 units of Nitinol Thermocouple Electrodes because they were packaged with an incorrect revision of the Instructions for Use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary correction for a documentation error (incorrect IFU revision) without reported injuries or illnesses, fitting the criteria for minor labeling/documentation issues.
Plain-English summary
Boston Scientific Neuromodulation Corporation has initiated a voluntary correction of 40 units of Nitinol Thermocouple Electrodes, 15 cm, 3m Cable. The recall is due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
The affected products are identified by Lot Number 23049684 and GTIN 00813250017519. These devices are indicated for use in RF heat lesioning of peripheral nerve tissue only and serve as temperature-sensing probes for the percutaneous treatment of pain.
The products were distributed nationwide in the United States, specifically in the states of AZ, CA, CO, FL, GA, ID, IL, IN, KY, MA, MD, MI, MO, NV, NY, OH, OK, OR, SC, TX, UT, VA, WA, and WI. Users should contact the manufacturer for further instructions regarding the correction.
The recalled product
- Product
- Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Category
- Medical Device — Neuromodulation
- Hazard
- Affected units
- 40
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 (3)
- TCN-15-3M
- GTIN: 00813250017519
- Lot Number:23049684
Distribution
Part of a larger recall action
This product is one of 5 recalled by Boston Scientific Neuromodulation 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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