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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 Initiated by Firm March 01, 2013
Date Posting Updated March 18, 2013
Recall Status1 Terminated 3 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
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LWS and Original Applicant = BOSTON SCIENTIFIC CORPORATION
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