Device Recall Alto DR ICD and Alto 2 DR ICD

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.

Cardiovascular Devices

3

Yes

Nationwide. AZ, CA, FL, IL, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, WA and WI.

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.