Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Sorin Platinium CRT-D 1741 DF-4 Recalled by Sorin CRM SAS Due to Hardware configuration may lead to overconsumption, followed by...

Date: July 9, 2018
Company: Sorin CRM SAS
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sorin CRM SAS directly.

Affected Products

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

Quantity: 10

Why Was This 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.

Where Was This Sold?

This product was distributed to 9 states: AZ, FL, IL, LA, MI, MS, NJ, OK, PA

Affected (9 states)Not affected

About Sorin CRM SAS

Sorin CRM SAS has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report