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U.S. Department of Health and Human Services

Class 2 Device Recall Alto VR ICD and Alto 2 VR ICD

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 Class 2 Device Recall Alto VR ICD and Alto 2 VR ICDsee related information
Date Initiated by FirmJuly 19, 2005
Date PostedSeptember 24, 2005
Recall Status1 Terminated 3 on January 28, 2007
Recall NumberZ-1597-05
Recall Event ID 32687
PMA NumberP980049/S6 
Product Classification Defibrillator, Implantable, Dual-Chamber - Product Code MRM
ProductAlto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Single chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.
Code Information devices manufactured between April 2003 and August 2004. Model 615 serial number: 237XG065.   Model 625 serial numbers: 243XI009, 243XI060, 243XI075, 243XI089, 246XI019, 246XI031, 246XI076, 249XI044, 249XI045,  249XI093, 249XI106, 249XI123, 249XI134, 304XI069,  304XI070, 304XI087, 304XI095, 304XI117, 307XI016,  307XI040, 307XI041, 307XI050, 307XI053, 307XI093, 307XJ016, 312XI007, 312XI009, 312XI016, 312XI033, 312XI033, 312XI041, 312XI095, 312XI097, 312XI124, 402XI027, 402XI070, 404XI007, 404XI010, 404XI028, 404XI029, 404XI031, 404XI044, 409XI001, 409XI007,  409XI013, 409XI015, 409XI018, 413XI004, 414XI017 and 415XI025. 
Recalling Firm/
Manufacturer		 ela Medical Llc
2950 Xenium Ln N Ste 120
Plymouth MN 55441-2623
Manufacturer Reason
for Recall		Devices manufactured prior to August 2004 may experience premature battery depletion and/or extended charge times which may affect the device's ability to function.
FDA Determined
Cause 2		Other
ActionA Dear Doctor letter dated 07/20/05 was sent describing the issue and providing recommendation that physicians follow-up with patients every 3 months. Patients who have frequent episodes of ventricular fibrillation or are pacemaker dependend may require prophylactic explantation or more frequent visits. A list of affected serial numbers was provided to each physician.
Quantity in Commerce51 total devices (1-model 615 & 50-model 625)
DistributionNationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = MRM
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