FDA recall Z-2824-2018

Product

Sorin Platinium CRT-D 1711 DF-1, 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.

Distribution

US distribution to: NJ, AZ, MS, OK, LA, PA, FL, MI, IL, and MS

Key facts

Status

Terminated

Initiation date

2018-07-09

Report date

2018-08-22

Termination date

2024-09-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Clamart Cedex, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2824-2018