Recall Z-2825-2018— Sorin CRM SAS

Name: FDA recall Z-2825-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-09

Class II · Terminated

Class II FDA medical device recall by Sorin CRM SAS, initiated 2018-07-09, terminated 2024-09-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator. 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..

Recalling firm: Sorin CRM SAS
Classification: Class II
Status: Terminated
Initiated: 2018-07-09
Terminated: 2024-09-06
Firm location: Clamart Cedex, France

Product description

Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.