Class 2 Device Recall Alto DR ICD and Alto 2 DR ICD

• Date Initiated by Firm: July 19, 2005
• Date Posted: September 24, 2005
• Recall Status: Terminated on January 28, 2007
• Recall Number: Z-1587-05
• Recall Event ID: 32687
• PMA Number: P980049/S3
• Product Classification: Defibrillator, Implantable, Dual-Chamber - Product Code MRM
• Product: Alto DR (model 614) and Alto 2 DR (model 624) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Dual 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 atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.
• Code Information: devices manufactured between April 2003 and August 2004. Model 614 serial numbers: 218XF003, 218XF012, 218XF014, 218XF022, 218XF042, 220XF012, 220XF014, 220XF017, 220XF018, 220XF019, 220XF020, 220XF030, 220XF038, 220XF061, 220XF062, 220XF064, 221XF018, 221XF042, 222XF034, 222XF074, 223XF057, 223XF059 and 223XF061. Model 624 serial numbers: 238XJ013, 238XJ023, 238XJ037, 244XJ044, 244XJ048, 244XJ062, 244XJ076, 244XJ079, 244XJ092, 246XJ022, 246XJ029, 246XJ048, 246XJ073, 246XJ081, 249XJ028, 249XJ048, 249XJ088, 249XJ160, 249XJ168, 304XJ002, 304XJ018, 304XJ023, 304XJ035, 304XJ041, 304XJ063, 304XJ072, 304XJ081, 304XJ086, 304XJ096, 304XJ100, 304XJ109, 304XJ113, 307XJ015, 307XJ049, 307XJ052, 307XJ057, 307XJ065, 307XJ124, 307XJ142, 307XJ153, 307XJ162, 307XJ171, 307XJ176, 307XJ220, 307XJ234, 307XJ241, 307XJ256, 313XJ013, 313XJ014, 313XJ025, 313XJ027, 313XJ033, 313XJ036, 313XJ038, 313XJ044, 313XJ046, 313XJ068, 313XJ071, 313XJ072, 313XJ081, 313XJ086, 313XJ088, 313XJ090, 313XJ092, 313XJ098, 313XJ104, 313XJ122, 313XJ134, 313XJ136, 313XJ137, 313XJ151, 313XJ158, 313XJ167, 313XJ167, 313XJ170, 313XJ178, 313XJ183, 313XJ191, 313XJ196, 313XJ198, 313XJ199, 313XJ205, 313XJ206, 313XJ210, 313XJ214, 313XJ215, 313XJ217, 313XJ224, 313XJ235, 313XJ235, 313XJ237, 313XJ242, 313XJ242, 313XJ245, 313XJ249, 313XJ250, 313XJ270, 313XJ275, 314XJ003, 314XJ006, 314XJ097, 314XJ102, 314XJ109, 314XJ134, 314XJ136, 314XJ139, 314XJ140, 314XJ148, 314XJ157, 314XJ158, 314XJ160, 314XJ174, 314XJ186, 314XJ187, 314XJ198, 314XJ212, 314XJ230, 314XJ239, 314XJ254, 314XJ256, 314XJ295, 339XJ012, 339XJ015, 339XJ016, 339XJ017, 339XJ019, 339XJ020, 339XJ023, 339XJ031, 339XJ034, 339XJ034, 339XJ037, 339XJ039, 339XJ041, 339XJ042, 339XJ048, 339XJ049, 339XJ050, 339XJ051, 339XJ053, 339XJ055, 339XJ057, 339XJ057, 340XJ001, 340XJ013, 340XJ014, 340XJ017, 340XJ024, 340XJ025, 340XJ030, 340XJ034, 340XJ040, 340XJ044, 340XJ045, 340XJ047, 340XJ051, 340XJ053, 340XJ057, 340XJ061, 340XJ062, 340XJ067, 340XJ076, 340XJ091, 340XJ092, 340XJ098, 340XJ106, 340XJ108, 340XJ117, 342XJ005, 342XJ006, 342XJ009, 342XJ016, 342XJ027, 345XJ002, 345XJ038, 345XJ048, 345XJ049, 345XJ050, 345XJ053, 345XJ064, 345XJ071, 349XJ001, 349XJ013, 349XJ014, 349XJ019, 349XJ020, 349XJ041, 350XJ010, 350XJ024, 350XJ025, 350XJ027, 350XJ030, 350XJ034, 350XJ040, 350XJ043, 350XJ056, 350XJ057, 350XJ060, 350XJ076, 350XJ076, 350XJ077, 350XJ080, 350XJ083, 351XJ003, 351XJ005, 351XJ007, 351XJ014, 351XJ018, 351XJ019, 351XJ020, 351XJ027, 351XJ029, 351XJ038, 351XJ067, 351XJ069, 351XJ075, 351XJ078, 351XJ082, 402XJ005, 402XJ018, 402XJ022, 402XJ023, 402XJ024, 402XJ026, 402XJ045, 402XJ053, 402XJ060, 402XJ061, 402XJ066, 402XJ074, 402XJ076, 402XJ078, 402XJ080, 402XJ085, 402XJ086, 402XJ087, 402XJ088, 403XJ007, 403XJ008, 403XJ017, 403XJ018, 403XJ026, 403XJ027, 403XJ031, 403XJ034, 403XJ040, 403XJ048, 403XJ050, 403XJ054, 403XJ060, 403XJ073, 403XJ086, 403XJ093, 403XJ095, 403XJ098, 403XJ100, 403XJ104, 403XJ105, 403XJ107, 405XJ003, 405XJ013, 405XJ030, 405XJ049, 405XJ053, 405XJ056, 405XJ067, 405XJ070, 406XJ031, 406XJ033, 406XJ035, 406XJ036, 406XJ039, 406XJ040, 406XJ044, 406XJ065, 406XJ069, 406XJ069, 406XJ070, 406XJ075, 407XJ035, 409XJ007, 409XJ009, 409XJ012, 409XJ017, 409XJ018, 409XJ020, 409XJ032, 409XJ034, 409XJ035, 409XJ037, 409XJ041, 409XJ043, 409XJ044, 409XJ046, 409XJ049, 409XJ052, 409XJ053, 409XJ054, 409XJ059, 410XJ004, 410XJ022, 410XJ026, 410XJ028, 410XJ030, 411XJ025, 411XJ035, 411XJ036, 411XJ042, 411XJ045, 411XJ049, 411XJ050, 411XJ054, 411XJ055, 411XJ057, 413XJ001, 413XJ004, 413XJ005, 413XJ006, 413XJ007, 413XJ009, 413XJ016, 413XJ017, 413XJ032, 413XJ040, 413XJ044, 413XJ049, 413XJ050, 413XJ051, 413XJ052, 413XJ054, 413XJ056, 413XJ061, 413XJ062, 413XJ067, 414XJ005, 414XJ009, 414XJ017, 414XJ037, 414XJ038, 414XJ039, 414XJ042, 414XJ047, 414XJ050, 414XJ063, 414XJ070, 414XJ074, 414XJ085, 414XJ093, 414XJ101, 414XJ102, 414XJ105, 414XJ107, 415XJ005, 415XJ022, 415XJ024, 415XJ033, 415XJ035, 415XJ037, 415XJ046, 415XJ068, 415XJ071, 415XJ094, 416XJ021, 416XJ035, 416XJ071, 417XJ057, 417XJ059, 417XJ064 and 418XJ010.
• Recalling Firm/ Manufacturer: ela Medical Llc; 2950 Xenium Ln N Ste 120; Plymouth MN 55441-2623
• Manufacturer 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.
• FDA Determined 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: 392 total devices (23-model 614 & 369-model 624)
• Distribution: Nationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MRM and Original Applicant = MicroPort CRM USA Inc.