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U.S. Department of Health and Human Services

Class 3 Device Recall VITALITY

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  Class 3 Device Recall VITALITY 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-0892-06
Recall Event ID 33716
PMA Number P960040S031 
Product Classification Implantable Pulse Generator, Pacemaker (Non-Crt) - Product Code LWP
Product VITALITY DS (model T125) and VITALITY 2 (models T165, 175) ICD (implantable cardiac defibrillator)
Code Information Model T125, serial numbers: 115233, 115234, 115237, 115239, 115240, 115241, 115335, 115370, 115399, 115400,  115479.    Model T165, serial numbers: 110803, 110806, 110830, 110833, 110835, 110836, 111081, 111270, 111271, 111273,  111274, 111299, 111329, 111332, 111333, 111337, 111339,  111442, 111493, 111611, 111687, 111842, 111844, 111886,  111979, 112029, 112174, 112175.   Model T175, serial number 109787. 
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 40
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 = LWP and Original Applicant = BOSTON SCIENTIFIC
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