Guidant Corporation VITALITY DS (model T125) and VITALITY 2 (models T165, 175) ICD (implantable cardiac defibrillator) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITALITY DS (model T125) and VITALITY 2 (models T165, 175) ICD (implantable cardiac defibrillator)
Brand
Guidant Corporation
Lot Codes / Batch Numbers
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.
Products Sold
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.
Guidant Corporation is recalling VITALITY DS (model T125) and VITALITY 2 (models T165, 175) ICD (implantable cardiac defibrillator) due to 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 settin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026