Cosman Medical Recalls Nitinol TC Reusable Electrodes Due to Epoxy Damage
Cosman Medical is recalling Nitinol TC Reusable Electrodes because epoxy damage after reprocessing can prevent the removal of blood and tissue residuals.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (inability to remove biological residuals) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Cosman Medical, LLC is recalling Nitinol TC Reusable Electrodes (TCN) under FDA recall number Z-0687-2018. The affected devices are indicated for use in radiofrequency (RF) heat lesioning of peripheral nerve tissue only. The recall involves 11,250 units distributed in the United States and Canada.
The recall is being conducted because, after multiple reprocessing cycles, the epoxy resin that holds the electrode in the hub can exhibit signs of damage. In some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilizing the device. This issue could compromise the device's ability to be properly cleaned and re-sterilized.
Healthcare facilities and users should stop using the affected TCN electrodes and contact Cosman Medical for instructions on how to return the devices. The specific model numbers and lot numbers affected are listed in the official FDA recall notice.
The recalled product
- Product
- Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) TCNK-20-C*, 13) TCN-5, 14) TCNK-20-R*, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10…
- Manufacturer
- Cosman Medical, LLC
Distribution
Distributed nationwide across the United States.
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