Boston Scientific CRM Corp CONTAK RENEWAL 3 AVT model numbers M150 and M155; CONTAK RENEWAL 3 AVT HE model numbers M157 and M159; CONTAK RENEWAL 4 AVT, model numbers M170 and M175; CONTAK RENEWAL 4 AVT HE model numbers M177 and M179. Cardiac Resynchronization Therapy Defibrillator. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue, St. Paul, MN 55112-5798, USA. CONTAK RENEWAL AVT models provide both atrial and ventricular tachyarrhythmia and cardiac resynchro Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CONTAK RENEWAL 3 AVT model numbers M150 and M155; CONTAK RENEWAL 3 AVT HE model numbers M157 and M159; CONTAK RENEWAL 4 AVT, model numbers M170 and M175; CONTAK RENEWAL 4 AVT HE model numbers M177 and M179. Cardiac Resynchronization Therapy Defibrillator. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue, St. Paul, MN 55112-5798, USA. CONTAK RENEWAL AVT models provide both atrial and ventricular tachyarrhythmia and cardiac resynchro
Brand
Boston Scientific CRM Corp
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Products Sold
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Boston Scientific CRM Corp is recalling CONTAK RENEWAL 3 AVT model numbers M150 and M155; CONTAK RENEWAL 3 AVT HE model numbers M157 and M15 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