Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions
Boston Scientific is voluntarily recalling 110 Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a documentation issue (incorrect Instructions for Use) with no reported injuries or illnesses, which aligns with the 'Low' severity criteria for packaging or documentation-only problems.
Plain-English summary
Boston Scientific Neuromodulation Corporation is voluntarily correcting a recall for 110 units of the Nitinol Thermocouple Electrode, 10 cm, 3m Cable. The recall is initiated because an incorrect revision of the Instructions for Use (IFU) was packaged with these products.
The affected products are identified by the code TCN-10-3M, GTIN 00813250017502, and Lot Numbers 23049683, 23239528, and 23239529. These devices 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 TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only. Users should verify the lot numbers of their devices against the recall list and contact the manufacturer for further instructions regarding the incorrect documentation.
The recalled product
- Product
- Nitinol Thermocouple Electrode, 10 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
- 110
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 (5)
- TCN-10-3M
- GTIN: 00813250017502
- Lot Numbers: 23049683
- 23239528
- and 23239529.
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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