ela Medical Llc: 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.

Recall number

Z-1587-05

Recalling firm

ela Medical Llc

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.

Status

Terminated

Initiated

2005-07-19

Posted

2005-09-24

Terminated

2007-01-28

Reason

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

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

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.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

["P980049/S3"]

Product code

MRM

Firm FEI

2182863

Firm city

Plymouth

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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