Clamart Cedex, France
Sorin CRM SAS recalls
1 recall recorded since 2018, most recently on 9 July 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 9 July 2018
- Terminated
- 6 September 2024
- Reason
- 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.
- Distribution
- US distribution to: NJ, AZ, MS, OK, LA, PA, FL, MI, IL, and MS
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2824-2018, Z-2825-2018
- Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
- Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.