Ad-Tech Spencer Probe Depth Electrodes Recalled for Incorrect Contact Count Labeling
Ad-Tech Medical Instrument Corporation is recalling 18 Spencer Probe Depth Electrodes because two units labeled as 8-contact were actually 6-contact. No patient impact was reported.
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 2/5 (Moderate).
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. The hazard is a labeling error where the device did not match its label, but the source explicitly states there was no impact to the patient, fitting the criteria for moderate severity involving minor labeling errors or low-risk issues without reported injury.
Plain-English summary
Ad-Tech Medical Instrument Corporation is recalling 18 units of the Spencer Probe Depth Electrode. The recall involves specific catalog numbers SD08R-SP05X-000 and SD06R-SP05X-000, with lot numbers 127219 and 127357. The devices are intended for temporary use in recording, monitoring, and stimulating electrical signals at the subsurface level of the brain.
The recall was initiated after an Ad-Tech Clinical Specialist attended a case on April 15, 2019, where a surgeon identified that two devices labeled as 8-contact depth electrodes were actually 6-contact depth electrodes. This labeling discrepancy was discovered during initial device testing after implantation. The source text states there was no impact to the patient due to this incident.
The affected units were distributed worldwide, including nationwide distribution in the state of Illinois and in Russia and the United Kingdom. Healthcare providers and patients should verify the contact count of their devices against the labeling and contact Ad-Tech Medical Instrument Corporation for further instructions.
The recalled product
- Product
- AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use…
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Hazard
- Affected units
- 18
Distribution
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