Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions
Boston Scientific is voluntarily correcting 43 units of Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 classified as FDA Class II and involves a documentation error (incorrect Instructions for Use) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary correction.
Plain-English summary
Boston Scientific Neuromodulation Corporation has initiated a voluntary correction for certain Cosman TCN Electrodes. The recall involves 43 units of the Nitinol Thermocouple Electrode, 5cm, specifically lot numbers 23263846 and 23263848. These devices are indicated for use in RF heat lesioning of peripheral nerve tissue and as temperature-sensing probes for the percutaneous treatment of pain.
The reason for the correction is that an incorrect revision of the Instructions for Use (IFU) was packaged with these products. The affected units 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.
Healthcare providers and patients who have these specific lot numbers should contact Boston Scientific Neuromodulation Corporation for further instructions on the correction. The agency classifies this as a Class II recall.
The recalled product
- Product
- Nitinol Thermocouple Electrode, 5cm - 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
- 43
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 (4)
- Nitinol Thermocouple Electrode
- 5 cm
- GTIN:00813250013047
- Lot Numbers: 23263846 and 23263848.
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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