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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Boston Scientific CRM Corp
Lot Codes / Batch Numbers
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Products Sold
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Boston Scientific CRM Corp is recalling VITALITY AVT, model A135 and A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular due to Guidant is revising its original recommendations set forth in the 06/17/05 physician letter because new information indicates that one of the original. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
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 noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026