Nucryo Vascular product recalled over labeling errors

Recall date

October 11, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Nucryo Vascular Inc. recalls The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems…

Recall number

Z-0507-2020

FDA classification

Class II

Brand / firm

Nucryo Vascular Inc.

Sold / distributed

U.S.: CA, TX, OK, AR, MI, MS. No foreign (OUS) distribution

Why it was recalled

Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon within a balloon design). The catheter is available in various working lengths and appropriate balloon diameters and lengths. The balloon has radiopaque markings to assist in balloon placement and to visualize proper expansion of the inflated balloon. The catheter tip is tapered to facilitate entry into peripheral arteries and across lesions. The catheter is designed to be used with appropriately sized guidewires and introducers.