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FDAApril 11, 2017device

INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular...

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

The hazard

Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.

What to do

FDA enforcement status: Terminated

Brands named

sorin group italia srl crfsorinsorin group

Recall history

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

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