VITALITY DS (model T125) and VITALITY 2 (models T165, 175) ICD (implantable cardiac defibrillator)
This recall has been terminated (originally issued May 23, 2006).
- Company
- Guidant Corporation
- Recall Initiated
- September 30, 2005
- Posted
- May 23, 2006
- Terminated
- January 16, 2007
- Recall Number
- Z-0892-06
- Quantity
- 40
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.