Ad-Tech Medical Recalls Depth Electrodes Due to Incorrect MR Safety Labeling
Ad-Tech Medical Instrument Corporation is recalling depth electrodes because supplemental information incorrectly stated they were approved for use in the MR environment.
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, but the source text describes a labeling error regarding MR safety without reporting any hospitalizations or injuries, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Ad-Tech Medical Instrument Corporation is recalling specific depth electrodes, including Foramen Ovale, Macro Micro, Spencer Probe, and Wyler Sphenoidal models. The recall involves 107,757 devices distributed nationwide and worldwide.
The recall was initiated because supplemental information provided with the devices incorrectly indicated that the subdural electrodes, depth electrodes, and anchor bolts were approved for use in the MR environment. The devices are not approved for such use.
The affected devices include all catalog numbers and lot numbers distributed through May 30, 2019. Users should stop using these devices in the MR environment and contact Ad-Tech Medical Instrument Corporation for further instructions.
The recalled product
- Product
- Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Hazard
- Affected units
- 107,757
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 (2)
- All catalog numbers and lot numbers distributed through May 30
- 2019
Distribution
Part of a larger recall action
This product is one of 3 recalled by Ad-Tech Medical Instrument 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.
See all 3 products in this recall →Related recalls
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