Devices

Device Recall LIVIAN Cardiac Resynchronization Therapy Defibrillator

Model / Serial
Model H220, serial numbers: 511302, 512322, 513553, 513555, 513592, 513617, 513637, 513638, 513641, 513653, 513741, 513876, 513883, 513886, 513888, 513906, 513940, 513951, 513954, 513988, 514010, 514029, 514033, 514041, 514044, 514047, 514060, 514065, 514070, 514080, 514105, 514107, 514121, 514129. Model H225, serial numbers: 562014, 562031, 562033, 562040, 562067, 562080, 562116, 562124, 562129, 562133. Model H227, serial numbers: 511024, 561060, 561618, 562179, 562439, 562789, 563298, 563319, 563323, 563342, 563350, 563366, 563391, 563395, 563400, 563411, 563470, 563484, 563532, 563535, 563547, 563589, 563608, 563615, 563616, 563624, 563662, 563714, 563771, 563785, 563799, 563801, 563804, 563820, 563823, 563824, 563825, 563829, 563831, 563832, 563833, 563840, 563845, 563846, 563847, 563852, 563853, 563854, 563855, 563908, 563918, 563934, 563957, 563962, 563967, 563970, 563972, 563976. Model H229, serial numbers: 560803, 560813, 560837, 560872, 560873, 560891, 560918, 560921, 560946, 560958, 560959, 560968, 560978, 560985, 561002, 561006, 561021, 561023, 561028, 561030, 561036, 561040, 561057, 561061, 561069, 561073, 561077, 561080, 561092, 561095, 561155, 561158, 561160.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
nationwide within US only (OUS distribution not affected).
Product Description
Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillators (CRT-Ds), provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure(HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue, St. Paul, MN 55112-5798 USA.
Manufacturer
Boston Scientific CRM Corp
1 Event
- Recall of Device Recall LIVIAN Cardiac Resynchronization Therapy Defibrillator

Manufacturer

Boston Scientific CRM Corp

Manufacturer Address
Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
Source
USFDA

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