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Sorin CRM SAS recalls Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrilla
Recalled August 22, 2018 · FDA recall Z-2825-2018 · Sorin CRM SAS
Hazard
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 Class II
Units
10
Sold at
US distribution to: NJ, AZ, MS, OK, LA, PA, FL, MI, IL, and MS
Description
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.
Product
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Manufacturer(s)
Sorin CRM SAS
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →