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Medical Device Recalls
Class 2 Recall
Guidant CONTAK RENEWAL 4 AVT
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Date Recall
Initiated |
May 15, 2006
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| Date Posted |
July 27, 2006
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| Recall Number |
Z-1290-06
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| Product |
CONTACT RENEWAL 4 AVT HE model numbers M177. Cardiac Resynchronization Therapy Defibrillator. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. CONTAK RENEWAK AVT models provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies
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| Code Information |
100160, 100161, 100162
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Recalling Firm/
Manufacturer |
Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul
, Minnesota
55112-5700
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| For Addition Information Contact |
Guidant
866-484-3268
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Reason For
Recall |
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.
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| 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.
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| Quantity in Commerce |
3
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| 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
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