FDA Medical Device Recalls (openFDA)
Boston Scientific CRM Corp: VITALITY AVT, model A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
- Recall number
- Z-1291-06
- Recalling firm
- Boston Scientific CRM Corp
- Product
- VITALITY AVT, model A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
- Status
- Terminated
- Initiated
- 2006-05-15
- Posted
- 2006-07-27
- Terminated
- 2008-03-02
- Reason
- Guidant has identified a pattern of premature battery depletion in devices manufactured with a single lot of capacitors from a single supplier. If function of this low voltage capacitor is compromised, the battery may deplete prematurely.
- Root cause
- Other
- Action
- An Urgent Medical Device Safety Information & Corrective Action letter, dated May 12, 2006, was sent to physicians. The letter gave a description of the issue, clinical implications, rate of occurrence, devices affected and recommendation. Physicians are asked to follow-up with affected patients as soon as possible because ERI to EOL time may be shortened. Physicians are asked to contact Guidant for instructions on performing a baseline 'save to disk' and provide this information to Guidant. Guidant will be able to analyze the device memory data and estimate remaining longevity and provide individualized follow-up and replacement guidelines. Subsequent follow-up visits should continue to monitor for evidence of premature battery depletion.
- Quantity
- 66
- Distribution
- Nationwide including Puerto Rico. Worldwide, including Argentina, Belgium, Canada, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, New Zealand, Portugal, Spain, Syrian Arab Republic, United Arab Emirates
- Lot, serial or model codes
- model A155, serial numbers: 113567, 113568, 113569, 113570, 113572, 113574, 113585, 113586, 113587, 113591, 113612, 113613, 113616, 113617, 113618, 113619, 113620, 113621, 113623, 113624, 113626, 113627, 113628, 113629, 113631, 113633, 113635, 113637, 113639, 113640, 113641, 113654, 113659, 113660, 113672, 113674, 113675, 113676, 113678, 113679, 113680, 113681, 113682, 113684, 113686, 113687, 113690, 113693, 113694, 113695, 113696, 113778, 113779, 113781, 113783, 113784, 113789, 113791, 113792, 113814, 113908, 113910, 113912, 113913, 113914, 114083
- 510(k) numbers
- not on file
- PMA numbers
- ["P960040/S29","P960040S035"]
- 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