ela Medical Llc 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
ela Medical Llc
Lot Codes / Batch Numbers
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.
Products Sold
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.
ela Medical Llc is recalling Alto MSP (model 617) and Alto 2 MSP (model 627) Implantable cardioverter Defibrillator. Ventricular due to Devices manufactured prior to August 2004 may experience premature battery depletion and/or extended charge times which may affect the device's abilit. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026