Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions
Boston Scientific is voluntarily correcting 437 units of Nitinol Thermocouple Electrodes because they were packaged with an incorrect revision of the 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation issue (incorrect Instructions for Use) with no reported injuries or illnesses, which aligns with the 'Low' severity criteria for documentation issues.
Plain-English summary
Boston Scientific Neuromodulation Corporation is conducting a voluntary correction of 437 units of Nitinol Thermocouple Electrodes, 10 cm. These devices are temperature-sensing probes indicated for use in RF heat lesioning of peripheral nerve tissue for the percutaneous treatment of pain.
The recall was initiated because 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.
The affected lot numbers are 23045871, 23049691, 23049693, 23049695, 23131523, 23131525, 23155050, 23155052, 23176308, 23213325, 23213326, 23235460, and 23235463. The product code is TCN-10 and the GTIN is 00813250013054. Healthcare providers and facilities should contact Boston Scientific Neuromodulation Corporation for further instructions regarding the correction of these devices.
The recalled product
- Product
- Nitinol Thermocouple Electrode, 10 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
- 437
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 (15)
- TCN-10
- GTIN:00813250013054
- Lot Numbers: 23045871
- 23049691
- 23049693
- 23049695
- 23131523
- 23131525
- 23155050
- 23155052
- 23176308
- 23213325
- 23213326
- 23235460
- and 23235463.
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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