The PolarCath Balloon Catheter consists of a coaxial catheter shaft with t ...



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.
Components:
Units Affected:    49
Recall Date:    Oct 11, 2019
Mfg:
Nucryo Vascular Inc.
Mfg Country:
United States
Recall ID:    84134
Product ID:    177384
Enforcement Date:    Nov 27, 2019
Termination Date:    May 3, 2021
Last Published:    May 3, 2021

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Emert Number:    Z-0507-2020
Emert Status:    Terminated