FDAOctober 28, 2015device

ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.

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

The hazard

Microcatheter may have circumferential defects (cracks) along its shaft.

What to do

FDA enforcement status: Terminated

Brands named

baylis medical corpbaylisbaylis medical

Recall history

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

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