Home / Recalls / Sorin CRM SAS / Z-2824-2018

Z-2824-2018 Class II Terminated

Recalled by Sorin CRM SAS — Clamart Cedex

Recall Details

Product Type
Devices
Report Date
August 22, 2018
Initiation Date
July 9, 2018
Termination Date
September 6, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16

Product Description

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 Pattern

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

Code Information

Model TDF033U, UDI GTIN 08031527015538 Serial Numbers: 619DK0FB, 618DK003, 619DK0C0, 622DK03B, 622DK12A, 624DK070, 624DK12F, 619DK021, 627DK0B0, 618DK0A4, 619DK097, 620DK065, 619DK09B, 619DK05F, 619DK088, 619DK0CC

Other recalls by Sorin CRM SAS

  • Z-2825-2018 Class II — Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator (July 9, 2018)