Sorin CRM SAS: Medical Device Recall in 2018 - (Recall #: Z-2825-2018)

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 1741 DF-4, 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-2825-2018

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: 10

Code Information:

Model TDF037U, UDI GTIN 08031527015484 Serial Numbers: 637DC0D0, 637DC13F, 625DC128, 622DC17A, 620DC034, 627DC0E0, 619DC101, 620DC07F, 622DC02C, 619DC0E1

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated