Reported Mar 13, 2013 · Terminated

Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording,…

Ad-Tech Medical Instrument Corporation

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ad-Tech Medical Instrument Corporation · 1901 William St · Racine, WI · 53404-1876

Is this the product you have?

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 electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Lot codes and dates: 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
QG24A-SP10N-000
QG26A-SP10N-000
QG32A-SP10X-000
QG32B-SP10X-000
QG36A-SP10N-000
QG36A-SP10X-000
QG36B-SP10N-000
QG44A-SP10X-000
QG53A-SP10X-000
QG66A-SP85N-000
QG69A-SP10N-000
QG88A-SP10X-000
QG96A-SP10N-000
QG96A-SP10X-000
QG96C-SP10X-000
QG96D-SP10X-000
QGC6A-SP07N-000
QGC8A-SP10N-000
QGC8A-SP10X-000
QGC8B-SP10X-000
QGC8C-SP10X-000
QGC8D-SP10N-000
QGC8E-SP10X-000
QGC8F-SP10X-000
QS20A-SP10N-000
QS40B-SP10X-000
Lot numbers208140314, 208140343, 208140344, 208140353, 208140354, 208140362, 208140369, 208140374, 208140381, 208140382, 208140387, 208140390, 208140395, 208140398, 208140399, 208140414, 208140417, 208140421, 208140431, 208140443, 208140445, 208140450, 208140452, 208140453, 208140458, 019020, 208140356R, 208140357R, 208140452R, C010180001, C702201001, C703160006, C704040001, C800250002, C800350004, C801240003, C802220003, C802220005, C802220006, C805210003, C805210004, C908221002, G012111001, G012140002, G015020002, G016240001, G017250004, G017250005, G017250006, G018011001, G018011002, G018011003, G019021002, G019021003, G019150003, G112270004, G114160001, G114160002, G115080002, G115170004, G115280005, G119020004, G211220001, G608060002, G704150001, G805270001, G900211002, G903011001, G903080003, S903080004, S905280003. Recall exanded on 5/2/2013 to include additional
Macro Micro Subdural ElectrodesREF
numbers (catalog numbers)
CG-64BPX-F436
CMMS-22PX-F478
CG-32BPX-F412
CGIE-98BPX-F341
CGIE-82BPN-F377
CMMS-69PN-F480
CGIE-98BPN-F341
CG-9SN-F496
CG-32BPX-F426
CG-16BPX-F445
CG-16BPX-F446
CG-256PX-F425
CGIE-39BPX-F442
CG-46BPX-F465
CG-64BPX-F419
CG-32BPX-F418
Lot numbers
20814044
208140447
208140463
208140463
208140476
208140463
08140463
208140424
208140439
G119221001
G212040002
G216040002
218190
208140431
208140450
208140432
208140433
208140420
208140437
208140450
208140422
208140422
208140422
208140422
Amount recalled: 144 (103 US; 41 OUS)

Where it was sold

Nationwide
CA
GA
LA
MA
MD
MI
MN
NH
PA
RI
TX
UT
WI
NY
IA

Why it was recalled

Stop using this product now

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 explanted. Recall expanded on 5/2/2013 to include additional Macro Micro Subdural Electrodes.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

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By hazard

Medical device recalls

Other recalls from Ad-Tech Medical Instrument Corporation

9 in total.

Where it was distributed

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