Z-2825-2018Class II

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

Name: Z-2825-2018 Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy...
Creator: Sorin CRM SAS
Published: 2018-07-09
License: https://open.fda.gov/license/

Sorin CRM SAS / initiated 2018-07-09 / Terminated / root cause: design

FDA source

Sorin CRM SAS began a recall of Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator on 2018-07-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2825-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-09
Posted: 2018-08-15
Terminated: 2024-09-06
Recalling firm: Sorin CRM SAS
Product: Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Product code: NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 07/09/2018, Urgent Field Safety Notices were mailed via certified postal service to physicians informing them about the removal of the non implanted Platinium devices that may present with this hardware failure and providing recommendations for managing implanted patients, which includes patient follow-up one month after discharge, and then every three months until the device nears the replacement date. Follow-up should include checking for battery status and system warnings. The firm recommends that patients be enrolled in remote monitoring. Physicians were instructed to fill out Customer Reply forms and ensure that all personnel involved in the management of patients implanted with affected devices are aware of the information outlined in the notice. For further assistance the firm provided 877-663-7674.
Quantity in commerce: 10
Distribution: US distribution to: NJ, AZ, MS, OK, LA, PA, FL, MI, IL, and MS
Product codes and lots: Model TDF037U, UDI GTIN 08031527015484 Serial Numbers: 637DC0D0, 637DC13F, 625DC128, 622DC17A, 620DC034, 627DC0E0, 619DC101, 620DC07F, 622DC02C, 619DC0E1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2825-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2824-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-15
Z-2825-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-15

Product code NIK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)