Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. S
FDA device recall Z-1597-05 · posted 2005-09-24 · Terminated
Recall details
- Recalling firm
- ela Medical Llc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MRM
- Quantity affected
- 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.
- Date initiated
- 2005-07-19
- Date posted
- 2005-09-24
- Date terminated
- 2007-01-28
- Location
- Plymouth, MN
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