Alto 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.
- Company
- Ela Medical Llc
- Recall Initiated
- July 19, 2005
- Posted
- September 24, 2005
- Terminated
- January 28, 2007
- Recall Number
- Z-1597-05
- Quantity
- 51 total devices (1-model 615 & 50-model 625)
- Firm Location
- Plymouth, MN
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.
Distribution
Nationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI.
Lot / Code Info
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.
Root Cause
Other
Action Taken
A 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.