FDA Medical Device Recalls (openFDA)
Guidant Corporation: VITALITY DS (model T125) and VITALITY 2 (models T165, 175) ICD (implantable cardiac defibrillator)
- Recall number
- Z-0892-06
- Recalling firm
- Guidant Corporation
- Product
- VITALITY DS (model T125) and VITALITY 2 (models T165, 175) ICD (implantable cardiac defibrillator)
- Status
- Terminated
- Initiated
- 2005-09-30
- Posted
- 2006-05-23
- Terminated
- 2007-01-16
- Reason
- 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.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- ["P960040S031"]
- Product code
- LWP
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28