Nucryo Vascular Inc.: Medical Device Recall in 2019 - (Recall #: Z-0507-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 11, 2019

Date Posted: November 27, 2019

Recall Number: Z-0507-2020

Event ID: 84134

Reason for Recall:

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

Status: Terminated

Product Quantity: 49

Code Information:

Lots: CAT 0738, CAT 0739, CAT 0740, CAT 0743, CAT 0744, CAT 0746, CAT 0750, CAT 0751, CAT 0758

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated