Sorin CRM SAS Recalls
2 recalls on record · August 22, 2018 to August 22, 2018 · Medical Devices
August 22, 2018Medical DevicesFDA
Sorin CRM SAS recalls Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrilla
Hazard: Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.
August 22, 2018Medical DevicesFDA
Sorin CRM SAS recalls Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrilla
Hazard: Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.