The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0892-2013·Announced 2013-03-13

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture and remain in the cortical tissue with the electrode is…"

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…
Manufacturer
Ad-Tech Medical Instrument Corporation
Category
Medical Device — Neurological Monitoring
Hazard

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

Distributed nationwide across the United States.

The notice also names 15 states specifically:

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