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U.S. Department of Health and Human Services

Class 2 Device Recall SQRX

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 Class 2 Device Recall SQRX see related information
Date Posted March 18, 2013
Recall Status1 Terminated on May 23, 2013
Recall Number Z-0965-2013
Recall Event ID 64546
PMA Number P110042 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
Product Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
Code Information SERIAL NUMBERS
A002804
A003105
A001493
A001784
A001981
A003024
A003197
A001609
A001594
A001733
A002291
A002348
A002373
A002195
A002710
A004131
A001942
A002278
A002399
A002402
A001021
A001136
A001104
A001193
A001392
A002093
A002147
A001134
A001155
A001063
A001011
A001102
A001012
A001004
A001058
A001010
A001140
A001093
A001170
A001055
A001185
A001144
A001217
A001215
A001241
A001367
A001377
A001405
A001431
A001380
A001468
A001411
A001639
A001688
A001734
A001578
A001654
A001799
A001916
A001903
A002127
A002076
A002425
A002686
297-899
300-895
292-887
A001120
A001085
A001109
A001089
A001122
A001110
A001020
A001052
A001023
A001051
A001062
A001148
A001042
A001106
A001091
A001096
A001126
A001237
A001341
A001354
A001447
A001429
A001533
A001481
A001236
A001119
A001246
A001384
A001267
A001731
A001650
A001774
A001856
A001980
A001752
A002364
A002823
A002826
A002833
A002858
A002889
A002892
A002946
A002997
A002996
A002953
A003386
A003465
A003066
A003382
A003426
A003540
A003563
A001291
A001463
A002985
A001146
A001174
A001040
A001005
A001053
A001180
A001195
A001194
A001188
A001233
A001270
A001273
A001197
A001294
A001368
A001338
A001332
A001152
A001423
A001344
A001443
A001235
A001317
A001363
A001512
A001513
A001538
A001489
A001480
A001334
A001500
A001820
A001680
A001647
A001652
A001630
A001696
A001789
A001740
A001781
A001271
A001711
A001661
A001573
A001772
A001636
A001682
A001750
A001437
A001882
A002050
A002036
A002045
A001910
A002015
A001888
A002068
A001605
A002005
A001860
A002234
A002300
A002337
A002087
A002295
A002272
A002141
A002261
A002243
A001958
A002266
A002014
A002071
A001768
A002158
A002286
A002403
A002194
A002228
A002292
A002418
A002252
A002342
A002459
A002374
A002424
A002485
A002276
A002523
A002027
A002376
A002672
A002645
A002267
A002553
A002608
A002737
A002999
A003124
A003138
A003285
A003449
A004002
A003886
A003694
A003842
A001732
A001660
A001800
A001427
A001418
A001428
A001441
A001454
A001635
A001566
A001697
A001653
A001634
A001811
A001623
A001837
A001793
A001745
A001905
A001863
A001867
A001887
A001588
A001808
A001953
A001859
A001690
A001729
A001692
A001872
A001871
A001908
A001822
A002013
A001550
A002083
A001932
A001952
A001923
A002095
A001832
A002134
A002135
A001824
A002003
A001875
A001987
A001853
A001850
A001817
A001975
A001739
A002082
A002111
A002017
A001896
A001843
A002165
A001920
A001990
A001695
A001962
A002102
A002339
A001801
A002113
A002136
A002084
A002235
A002105
A002150
A002143
A002118
A002022
A002204
A002211
A002069
A001963
A001970
A001861
A002210
A002397
A001847
A002101
A002131
A002157
A001960
A002232
A002098
A002103
A001985
A001629
A002175
A001792
A002160
A002249
A002250
A002199
A002188
A002289
A002318
A002400
A002110
A002242
A002254
A002213
A002312
A002223
A001921
A002224
A002393
A002077
A002075
A002315
A002361
A001993
A002251
A002226
A002420
A002156
A002245
A002125
A001876
A002177
A002370
A002241
A002230
A001865
A002427
A001597
A002416
A001753
A002338
A002369
A002454
A001727
A002349
A002423
A002326
A002203
A002434
A002458
A002461
A002382
A002407
A002336
A002575
A002323
A002537
A002499
A002139
A002356
A002367
A002438
A002383
A002448
A002457
A002647
A001787
A002311
A002408
A002661
A002529
A001880
A002255
A002554
A002299
A002595
A002366
A002006
A002675
A002462
A002325
A002592
A002653
A002507
A002616
A002472
A002107
A002428
A002117
A002603
A002715
A002572
A002587
A002417
A002586
A002598
A002582
A002535
A002629
A002617
A002518
A002599
A002649
A002638
A002679
A002631
A002431
A002774
A002779
A002551
A002716
A002557
A002628
A002640
A002687
A002803
A002677
A002761
A002786
A002784
A002674
A00269
Recalling Firm/
Manufacturer
Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul MN 55112-5700
651-582-4000
For Additional Information Contact
651-582-4000
Manufacturer Reason
for Recall
An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.
FDA Determined
Cause 2
Software design
Action Consignees were sent a Boston Scientific "Important Medical Device Information" letter dated March 1, 2012. The letter was addressed to "Dear Doctor". The letter described the product involved in the recall, the problem and provided Recommendations/Actions. US customers may contact Technical Services for more information at 800-227-3422.
Quantity in Commerce 2090 (570 USA; 1520 OUS)
Distribution Worldwide Distribution, USA including the states of AZ, CA, CO, DC, GA, IL, MD, MA, MN, NJ, NY, NC, OH, PA, SC, VA, WA and the countries of AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NEW ZEALAND, PORTUGAL, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, and the UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LWS and Original Applicant = BOSTON SCIENTIFIC CORPORATION
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