Alto MSP (model 617) and Alto 2 MSP (model 627) Implantable cardioverter Defibrillator. Ventricular antitachycardia pacing. Dual chamber arrhythmia detection. biventricular 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 atrial and 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-1598-05
- Quantity
- 20 total devices (3-model 617 & 17-model 627)
- 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 617 serial numbers: 241XH059, 305XH005 and 305XH014. Model 627 serial numbers: 330YA541, 348YA563, 348YA571, 348YA573, 348YA576, 350YA594, 407YA604, 407YA630, 407YA635, 407YA644, 411YA001, 411YA002, 411YA011, 411YA014, 411YA015, 411YA016 and 418YA029.
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.