FDAJune 24, 2015device

The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug...

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

The hazard

The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.

What to do

FDA enforcement status: Terminated

Brands named

ekos

Recall history

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

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The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug... — Recall Details · AllClear