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FDAJuly 9, 2018device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

sorin crm sassorinsorin crm

UPCs

08031527015538

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator — Recall Details · AllClear