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.
FDA Recall Z-1108-05 · Posted 2005-08-16
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Recalling FirmBoston Scientific CRM Corp
Recall StatusTerminated
Product CodeLWP
Date Initiated2005-07-25
Date Terminated2008-04-07
Product Quantity22,575 devices (approximately 19,000 currently implanted worldwide)
Reason for Recall
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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