PLATINIUM recallZ-2824-2018 · Sorin CRM SAS · initiated Jul 9, 2018

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Sorin CRM SAS or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number: Z-2824-2018
Status: Terminated
Initiated by the company: Jul 9, 2018
Recalling firm: Sorin CRM SAS
Quantity: 16
Product code: NIK
FDA submissions: P060027S079
Distribution: US distribution to: NJ, AZ, MS, OK, LA, PA, FL, MI, IL, and MS

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

PLATINIUM CRT-D 1711
Microport Crm Srl · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
1 recall5 reports

Product lines

PLATINIUMMicroport Crm Srl · 4 models · 14 reports · 2 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 80636).

Z-2825-2018 · Terminated
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

How recalls are matched to devices · Editorial policy · Report an error on this page