Ad-Tech Macro Micro Subdural Electrodes Recalled for Sharp Edges
Ad-Tech Medical Instrument Corporation is recalling Macro Micro Subdural Electrodes because they may have sharp edges or fracture, posing a risk of injury to brain tissue.
What this means for you
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 involves a medical device with a defect (sharp edges/fracture) that poses a risk of harm (abrasion of cortical surface) to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ad-Tech Medical Instrument Corporation is recalling 144 units of Macro Micro Subdural Electrodes. These devices are intended for temporary use (less than 30 days) to record, monitor, and stimulate electrical signals on the surface of the brain. The recall was expanded on May 2, 2013, to include additional catalog numbers and lot numbers.
The recall was initiated because the microelectrodes are not flush with the silastic substrate. This defect may result in sharp edges capable of abrading the cortical surface. Additionally, remaining pieces of the electrode may fracture and remain in the cortical tissue when the device is explanted.
The affected units were distributed worldwide, including nationwide in the United States and in specific countries such as Australia, Canada, England, Japan, Korea, Spain, France, and Switzerland. Users should contact Ad-Tech Medical Instrument Corporation for instructions on how to return or replace the affected devices.
The recalled product
- Product
- Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of elect
- Manufacturer
- Ad-Tech Medical Instrument Corporation
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 (20)
- REF numbers (catalog numbers): EG10A-SP10N-000
- EG34B-SP10X-000
- EGD7A-MP12N-000
- EGE4A-SP10N-000
- EGE4A-SP10X-000
- QG10B-SP10X-000
- QG10C-SP10N-000
- QG10D-SP10N-000
- QG11A-SP10X-000
- QG16A-SP10X-000
- QG17A-SP10X-000
- QG18A-SP10N-000
- QG18A-SP10X-000
- QG20B-SP10N-000
- QG20B-SP10X-000
- QG20C-SP10N-000
- QG20C-SP10X-000
- QG20D-SP10X-200
- QG20E-SP10X-000
- QG20F-SP10X-000
Distribution
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