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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 21, 2004
Date Posted November 04, 2004
Recall Status1 Terminated 3 on November 14, 2005
Recall Number Z-0176-05
Recall Event ID 30273
PMA Number P980049/S3 P980049/S6 
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Alto implantable cardioverter defibrillator
Code Information Model Numbers DR model 614, VR model 615
Recalling Firm/
ela Medical Llc
2950 Xenium Ln N Ste 120
Plymouth MN 55441-2623
Manufacturer Reason
for Recall
Alto Implantable Defibrillators Models 614 and 615. These models can experience sudden no output, and early end of life characteristics due to metal migration in their controlling hybrids, causing high current drain leading to premature battery depletion.
FDA Determined
Cause 2
Action The company observed occurrences of premature battery depletion and/or prolonged charge time for some Alto 614 and Alto 615 devices. The firm is requesting physician's assistance to monitor the performance of a limited number of implanted Alto 614 and 615 devices.
Quantity in Commerce 434 users recived the product
Distribution Nationwide. Devices were received from the manufacturer in France. After received in the US, No devices were distributed from the US to foreign consignees. 95 physicians received the recalled product. ELA Medical has contacted physicians who follow patients implanted with the devices that are the subject of the correction. It should be noted that in many cases, the physician following the patient is not the physician who implanted the device. Because ELA is requesting assistance to monitor the performance of implanted devices, this notification is directed at the physicians who are following the patients.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LWS and Original Applicant = MicroPort CRM USA Inc.