Sunday, April 07, 2013

Ad-Tech Medical Instrument Corporation Issues Global Recall of Macro Micro Subdural Electrodes


On December 18, 2012 Ad-Tech Medical Instrument Corporation initiated a recall of 115 Macro Micro Subdural Electrodes. There is a concern the microelectrodes are not flush with the silastic surface. As a result, there is the potential for abrasion of cortical brain tissue and the existence of fractured pieces remaining in the cortical tissue when the electrode is explanted, which may result in hemorrhage or damage to cortical fibers, leading to infarct or seizure activity.
Recalled Product(s) were manufactured from June 2006 to March 2012, and distributed from June 8, 2006 to March 14, 2012.
The following Macro Micro Subdural Electrodes have been recalled:
CATALOG NUMBERS
LOT NUMBER
BATCH
NUMBER
QTY
QGC8A-SP10N-OOO
G608060002
0020161
1
QGC8D-SP10N-OOO
C704040001
0025418
1
QGC8A-SP10N-OOO
G704150001
0026119
1
QGC8A-SP10N-OOO
C703160006
0026358
2
EGE4A-SP10N-OOO
C702201001
0029304

1
QGC8A-SP10N-OOO
C805210003
0030815
1
QG36A-SP10N-000
C805210004
0030819
2
QG36A-SP10N-OOO
C802220003
0031061
1
QGC8A-SP10N-OOO
C802220005
0031035
1
EGE4A-SP10N-OOO
C802220006
0031104
0031094
2
EGE4A-SP10N-OOO
C801240003
0032308
2
EGE4A-SP10N-OOO
C800250002
0033276
1
EGE4A-SP10N-OOO
C800350004
0033277
1
EGE4A-SP10N-OOO
G805270001
0034692
1
QGC8B-SP10X-OOO
208140314
0038610
1
EGE4A-SP10X-OOO
208140314
0038520
0038521
0038522
3
QGC8A-SP10N-OOO
G903080003
0041526
1
QG36A-SP10N-OOO
5903080004
0041659
1
QS20A-SP10N-OOO
5905280003
0042295
1
QGC8C-SP10X-OOO
208140343
0043004
1
QGC8B-SP10X-OOO
208140344
0043076
1
EGD7A-MP12N-OOO
G903011001
0043905
1
EGD7A-MP12N-OOO
G900211002
0044215
1
QG18A-SP10N-OOO
C908221002
0044840
2
QG16A-SP10X-OOO
208140353
0044772
2
QG18A-SP10X-OOO
208140353
0044835
2
QGC8B-SP10X-OOO
208140354
0044932
1
QGC8A-SP10N-OOO
G015020002
0045573
1
QG20B-SP10N-OOO
019020
0045227
3
QG53A-SP10X-OOO
208140362
0046112
1
QG96A-SP10N-OOO
G012140002
0047160
1
QG66A-SP85N-OOO
G016240001
0047248
1
QG96A-SP10X-OOO
208140369
0047159
1
QGC8D-SP10N-OOO
G019150003
0048115
1
QG26A-SP10N-OOO
G017250004
0048221
1
QG36B-SP10N-OOO
G0172S0005
0048224
1
EG10A-SP10N-OOO
G017250006
0048181
1
QG96A-SP10X-OOO
208140374
0047724
1
EG34B-SP10X-OOO
208140381
0048753
1
QG20E-SP10X-OOO
208140382
0048898
1
QG20D-SP10X-200
208140382
0048899
1
QGC8E-SP10X-OOO
208140382
0048901
1
QG36A-SP10N-OOO
C010180001
0050030
2
QG36A-SP10X-OOO
208140387
0050031
2
QG17A-SP10X-OOO
208140390
0050218
1
QG18A-SP10X-OOO
208140395
0051090
2
QG20F-SP10X-OOO
208140398
0051181
1
QG10B-SP10X-OOO
208140398
0051442
1

QG18A-SP10N-OOO

G012111001
0051906

1
QG18A-SP10N-OOO
G018011001
0051663
1
QG10C-SP10N-OOO
G018011003
0051667
2
QG10D-SP10N-OOO
G018011002
0051675
2
QG11A-SP10X-OOO
208140399
0051598
2
QG10C-SP10N-OOO
G019021002
0052519
2
QG10D-SP10N-OOO
G019021003
0052260
2
QGC8B-SP10X-OOO
208140356R
0044932
1
QGC6A-SP07N-OOO
G119020004
0053503
1
QG20B-SP10X-OOO
208140357R
0045319
1
QG16A-SP10X-OOO
208140414
0054443
3
QG16A-SP10X-OOO
208140417
0055275
1
QGC8F-SP10X-OOO
208140421
0055934
1
QG36A-SP10N-OOO
G114160002
0056510
1
QG10C-SP10N-OOO
G114160001
0056441
1
QG36A-SP10N-OOO
G115170004
0057159
1
QG20C-SP10N-OOO
G112270004
0057110
2
QG96C-SP10X-OOO
208140431
0057422
1
QS40B-SP10X-OOO
208140431
0057284
1
QG36A-SP10N-OOO
G115080002
0057839
1
QG24A-SP10N-OOO
G115280005
0058246
2
QG20B-SP10X-OOO
208140357R
0045319
1
QG20B-SP10X-OOO
208140357R
0045319
1
QG20C-SP10X-OOO
208140443
0059392
1
QGC8A-SP10X-OOO
208140443
0059234
1
QG18A-SP10X-OOO
208140443
0059248
1
QG11A-SP10X-OOO
208140445
0059777
1
QG32A-SP10X-OOO
208140450
0060750
1
QG32B-SP10X-OOO
208140450
0060751
2
QG96C-SP10X-OOO
208140450
0060500
1
QG96D-SP10X-OOO
208140450
0060740
2
QG16A-SP10X-OOO
208140452
0060830
0060878
2
QG18A-SP10X-OOO
208140452
0060879
2
QG88A-SP10X-OOO
208140452R
0060885
1
QG44A-SP10X-OOO
208140453
0061307
2
QG69A-SP10N-OOO
G211220001
0062673
1
QG36A-SP10X-OOO
208140450
0059620
2
QG36A-SP10X-OOO
208140458
0061050
1
Product(s) can be identified by the label provided on the packaging.
Ad-Tech Medical Instrument Corporation voluntarily recalled the Macro Micro Subdural Electrodes after becoming aware of potential harm to the patient. Ad-Tech Medical Instrument Corporation has notified the FDA of this action.
There has been one reported serious injury that may have been related to the use of the device.
http://www.fda.gov/Safety/Recalls/ucm341680.htm