Subdermal Needle Electrodes Recalled Due to Burn Risk During MRI Procedures
Technomed Europe is recalling disposable subdermal needle electrodes because patients may suffer burns if electrodes are left in place during MRI scanning. The manufacturer failed to provide adequate safety information in the device instructions.
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: FDA Class II medical device with documented potential for serious burn injury if left in place during MRI scanning due to inadequate safety warnings. No illnesses or injuries have been reported; the hazard is theoretical rather than realized, meeting the criterion for High severity.
Plain-English summary
Technomed Europe is recalling 37 boxes of Disposable Subdermal Needle Electrodes (product number TE/S46/638, 12 x 0.40mm, 25 needles per package) distributed nationwide in California, Florida, New Hampshire, Ohio, and Washington.
The electrodes may cause burns of varying severity to patients if left in place while the patient is in an MRI scanner. The manufacturer provided inadequate safety information in the device's Instructions for Use, failing to warn users of this critical risk during MRI procedures.
Affected lot numbers include 044220 (exp. 1/1/2023), 045077 (exp. 3/1/2023), 045443 (exp. 4/1/2023), and 049285 (exp. 7/1/2024). Healthcare providers and patients should not use these electrodes during MRI procedures without first removing them. Contact Technomed Europe if you have electrodes from these lots or have questions about this recall.
The recalled product
- Product
- Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
- Manufacturer
- Technomed Europe
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 (9)
- Lot numbers 044220
- exp. 1/1/2023
- 045077
- exp. 3/1/2023
- 045443
- exp. 4/1/2023
- and 049285
- exp. 7/1/2024
- UDI-DI 08718375861530.
Distribution
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