Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions
Boston Scientific is voluntarily recalling 118 units of Nitinol Thermocouple Electrodes because they were packaged with incorrect 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 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 precautionary recall.
Plain-English summary
Boston Scientific Neuromodulation Corporation is voluntarily recalling 118 units of Nitinol Thermocouple Electrodes, 15 cm. The recall is initiated because an incorrect revision of the Instructions for Use (IFU) was packaged with these products.
The affected 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 recall covers specific lot numbers: 23014533, 23049687, 23049688, and 23192881.
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. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- Nitinol Thermocouple Electrode, 15 cm - 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
- 118
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 (6)
- TCN-15
- GTIN:00813250013061
- Lot Numbers: 23014533
- 23049687
- 23049688
- and 23192881.
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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