FDA Medical Device Recalls (openFDA)
Boston Scientific CRM Corp: VITALITY AVT, model A135 and A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Sterilized using gaseous ethylene oxide. Guidant Corporation Caridac Rhythm Managment, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
- Recall number
- Z-1108-05
- Recalling firm
- Boston Scientific CRM Corp
- Product
- VITALITY AVT, model A135 and A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Sterilized using gaseous ethylene oxide. Guidant Corporation Caridac Rhythm Managment, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
- Status
- Terminated
- Initiated
- 2005-07-25
- Posted
- 2005-08-16
- Terminated
- 2008-04-07
- Reason
- Guidant is revising its original recommendations set forth in the 06/17/05 physician letter because new information indicates that one of the original recommendations can increase the risk of a latching event, which may limit available therapy.
- Root cause
- Other
- Action
- Urgent Medical Device Safety Information & Corrective Action letter dated 07/22/05 was either mailed or Federal Expressed to doctors. This letter informed doctors that Guidant was revising its original recommendations set forth in the June 17, 2005 letter because new information indicates that one of the original recommendations can increase the risk of a latching event. Contained in this letter were Clinical Implications and Revised Recommendations.
- Quantity
- 22,575 devices (approximately 19,000 currently implanted worldwide)
- Distribution
- Worldwide. In addition to the US other countries include: Argentina, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Syrian Arab Republic, Turkey, US - Virgin Islands and United Kingdom.
- Lot, serial or model codes
- all serial numbers
- 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