Z-1597-05

Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventricular...

Name: Z-1597-05 Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventricular...
Creator: ela Medical Llc
Published: 2005-07-19
License: https://open.fda.gov/license/

Ela Medical, Inc. / initiated 2005-07-19 / Terminated / root cause: manufacturing process

FDA source

ela Medical Llc began a recall of Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Single chamber arrhythmia detection... on 2005-07-19. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1597-05
Status: Terminated
Initiated: 2005-07-19
Posted: 2005-09-24
Terminated: 2007-01-28
Recalling firm: Ela Medical, Inc.
Product: 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.
Product code: MRM Defibrillator, Implantable, Dual-Chamber
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.
Root cause tag: manufacturing process
FDA root cause: Other
Action: 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.
Quantity in commerce: 51 total devices (1-model 615 & 50-model 625)
Distribution: Nationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI.
Product codes and lots: 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.

Product code MRM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)