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U.S. Department of Health and Human Services

Class 3 Device Recall CONTAK RENEWAL 3

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  Class 3 Device Recall CONTAK RENEWAL 3 see related information
Date Initiated by Firm September 30, 2005
Date Posted May 23, 2006
Recall Status1 Terminated 3 on January 16, 2007
Recall Number Z-0890-06
Recall Event ID 33716
PMA Number P010012S008 
Product Classification Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
Product CONTAK RENEWAL 3 CRT-D (model no. H170, H175, H177, H179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. CONTAK RENEWAL 3 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.
Code Information Model H170, serial numbers: 360449, 360632, 360655, 360657, 360661, 360666, 360714, 360719, 360721, 360738,  360741, 360742, 360743, 360745, 360746, 360749, 360756,  360758, 360763, 360766, 360790, 360791, 360792, 360796,  360800, 360802, 360844, 360847, 360848, 360861, 360863,  360904, 360907, 360908, 360910, 360986, 360987, 360988,  360989, 360991.  Model H175 serial numbers: 310338, 310434, 310523, 310532, 310533, 310537, 310544, 310545, 310706, 310707,  310709, 310713, 310719, 310721, 310734, 310735, 310737,  310746, 310753, 310796, 310798, 310813, 310907, 310908,  310909, 310913, 310916, 310976, 310990, 310996, 311007,  311010, 311011, 311013, 311015, 311016, 311092, 311096,  311152, 311154, 311181, 311185, 311386, 311389.   Model H177, serial numbers: 280992, 281011, 281012, 281017, 281020, 281021, 281022, 281024, 281045, 281056,  281066, 28107, 281077, 281119, 281121, 281123, 281124,  281126, 281127, 281143, 281175, 281213, 281233, 281247,  281320, 281356, 281364, 281368, 281371, 281376, 281385,  281401, 281403, 281413, 281476, 281480, 281484, 281485,  281491, 281533, 281539, 281542, 281544, 281559, 281562,  281580.   Model H179, serial numbers: 110905, 110907, 110908, 110950, 110952, 110954, 110955, 110958, 110980, 110983,  110987, 110988, 111000, 111001, 111003, 111004, 111007,  111012, 111024, 111041, 111042, 111128, 111173, 111180,  111198, 111201, 111248, 111250, 111254, 111263, 111294,  111299, 111308, 111313, 111334, 111335, 111336, 111338,  111340, 111341, 111342, 111346, 111350, 111352, 111390,  111391, 111392, 111393, 111397, 111422.  
Recalling Firm/
Manufacturer		 Guidant Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5798
Manufacturer Reason
for Recall		 Devices manufactured with batteries built on April 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier.
FDA Determined
Cause 2		 Other
Action Guidant issued a Physicain letter, dated 10/25/05 to implanting/following physicians. The letter states the issues and reommends patient follow-up care every three months, as stated in published labeling. An Advisory Update, dated 12/20/05, was sent to physicians that describes the issue, states that here have been zero reports of battery weld failures on implanted devices and the results of laboratory testing (accelerated testing) in which they tried to induce the failure. The results of the testing induced 2 battery weld post failures. A projected rate of occurence was also given. Patient management recommendations have not changed.
Quantity in Commerce 180
Distribution Nationwide (AL, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI). OUS to include: Australia, France, Germany, India, Ireland, Israel, Italy, Netherlands, Norway, South Africa, Spain, Switzerland, Turkey, 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 = NIK and Original Applicant = Boston Scientific Corp.
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