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U.S. Department of Health and Human Services

Class 2 Device Recall Guidant CONTAK RENEWAL 3 RF & 4 RF

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  Class 2 Device Recall Guidant CONTAK RENEWAL 3 RF & 4 RF see related information
Date Initiated by Firm September 30, 2006
Date Posted December 16, 2006
Recall Status1 Terminated 3 on April 01, 2007
Recall Number Z-0269-2007
Recall Event ID 36495
PMA Number P010012-Rene 
Product Classification Defibrillator - Product Code LWP
Product Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219) ,CONTAK RENEWAL 4 RF (model H230), and CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
Code Information Model H210, serial numbers: 204765, 204766, 204767, 204769, 204770, 204771, 204772, 204773, 204774, 204777, 204784, 205492, 205494, 205495, 205497, 205498, 205504, 205507, 205512, 205523, 205525.   Model H215, serial numbers: 703984, 703985, 703986, 704415, 704417, 704418, 704421, 704422, 704423, 704424, 704425.   Model H217, serial numbers: 704509, 704531, 704534, 704545, 704547, 704550, 705267, 705294, 705335, 705350.   Model H219, serial numbers: 203320, 203344, 203355, 203377, 203382.   Model H230, serial numbers: 201149, 201150, 201151, 201152, 201153, 201154, 201155.   Model H239, serial numbers: 650451, 650453, 650454.
Recalling Firm/
Manufacturer		 Guidant Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
Manufacturer Reason
for Recall		 Shock Effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise effectiveness of shock therapy. While no energy is lost, defibrillation thresholds may be higher (and safety margin may be reduced) because the shocking vector has changed.
FDA Determined
Cause 2		 Other
Action An Important Medical Device Information letter, dated 10/09/2006 was sent to physicians following patients with a potentially affected device. The letter describes the issue, provides for a projected rate of occurrence, and provides recommendations. An October 9, 2006 Product Advisory Letter, beginning October 30, 2006, was also sent to provide an update that further laboratory testing and analysis indicates that the nominal probability of malfunction is higher than their earlier prediction. Non-implanted devices have been retrieved.
Quantity in Commerce 57 (46-USA, 11 Foreign- Renewal 4RF)
Distribution Worldwide distribution ---- including states of CA, FL, GA, IA, IL, KY, MA, MO, NJ, NY, OH, PA, TX and countries of Italy, Netherlands, Sweden, 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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