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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiac Resynchronization Therapy Defrillator

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  Class 2 Device Recall Cardiac Resynchronization Therapy Defrillator see related information
Date Initiated by Firm March 04, 2009
Date Posted July 17, 2009
Recall Status1 Terminated 3 on October 04, 2012
Recall Number Z-1620-2009
Recall Event ID 51345
PMA Number P010012S008 
Product Classification Pulse-generator, dual chamber, implantable - Product Code LWP
Product Guidant Contak¿ Renewal¿ 3 CRT-D Model H170; 3CRT-D, Model H175; 3HE CRT-D, Model H177; 3HE CRT-D, Model H179; 4CRT-D REF H190; 4CRT-D REF H195; 4HE CRT-D REF H197; 4HE CRT-D REF H199; 4AVT CRT D, REF M177; 4AVT HE CRT-D REF 179. Cardiac Resynchronization Therapy Defibrillator, Sterile EO, Guidant Corporation, 4100 Hamline Avenue North, St Paul, MN 55112-5798.

Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
Code Information SERIAL NUMBERS FOR MODEL #H170 :  361904, 363420, 363895, 364293, 364294, 364349, 364350, 364470, 364480, 364485, 364486, 364494, 364510, 364539, 364617 and 364621; and  SERIAL NUMBERS MODEL #H175:  312616, 312962, 312965, 312973, 313064, 315207, 315209, 315212, 315213, 315219, 315227, 315238, 315248, 315251, 315265, 315398, 315431, 315446, 316045, 316064 and 316123; and  SERIAL NUMBERS MODEL #H177:  281692, 282937, 284803, 284874, 284896, 285009, 285019, 285091, 285110, 285111, 285120, 285134 285332 and 285357; and  SERIAL NUMBERS MODEL #H179:  111439, 112977, 113822, 113910, 114275, 114375, 114394, 114488, 114503, 114506, 114515, 114523, 114652, 114680, 114682 and 114714; and  SERIAL NUMBERS MODEL #H190:  312166, 311764, 311803, 311894, 312164 and 312177; and  SERIAL NUMBERS MODEL #H195:  352084, 353252, 353389, 351230, 353157 and 353388; and  SERIAL NUMBERS MODEL #H197:  310113, 310253, 310651, 310335, 310337, 310339, 310342, 310357, 310361, 310442, 310464, 310465, 310518, 310660, 310691, 310696, 310814, 310933 and 311096; and  SERIAL NUMBERS MODEL #H199:  321405, 321060, 321415, 321423, 321478, 321489, 321494, 321498 and 321689; and  SERIAL NUMBERS MODEL #M177:  200050 and 200051; and  SERIAL NUMBERS MODEL #M179:  200098, 200099 and 200033.
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		 In April 2007, Boston Scientific CRM communicated with physicians regarding the potential for reduced Elective Replacement Indicator (ERI) to Battery End of Life (EOL) time in a subset of implantable defibrillators due to degradation of a low-voltage capacitor. Since that time, the April 2007 advisory population has not experienced any clinically significant changes to either the rate of occurrenc
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Boston Scientific CRM notified Doctors via sales representatives of an "Urgent Medical Device Information" letter dated March 4, 2009. The letter described the problem and included Description of Issue, Rate of Occurrence, Patient Management Recommendations, Devices Affected, Warranty Program & Further Information. A Boston Scientific " Product Advisory" letter dated March 4, 2009, was also made available to physicians to distribute to patients. The letter informed the patient that their defibrillator was included in a group of devices that might experience a performance issue. For further questions, Contact Boston Scientific CRM at 1-800-227-3422.
Quantity in Commerce 112
Distribution Worldwide Distribution - US including PR and states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI and WY and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, JAPAN, LEBANON, NETHERLANDS, NEW ZEALAND, POLYNESIA, PORTUGAL, SPAIN, SWITZERLAND, TURKEY and 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 = LWP and Original Applicant = Boston Scientific Corp.
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