Sorin CRM SAS recalls Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrilla…

Recall date

July 9, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2824-2018

FDA classification

Class II

Brand / firm

Sorin CRM SAS

Sold / distributed

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

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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