Class 2 Device Recall SQRX

• Date Initiated by Firm: March 01, 2013
• Date Posted: March 18, 2013
• Recall Status: 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 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• 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: 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