Sorin CRM SAS: Medical Device Recall in 2018 - (Recall #: Z-2824-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

Product Classification:

Class II

Date Initiated: July 9, 2018

Date Posted: August 22, 2018

Recall Number: Z-2824-2018

Event ID: 80636

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.

Status: Terminated

Product Quantity: 16

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated