# FDA recall Z-0507-2020

> **Nucryo Vascular Inc.** · Class II · device recall initiated 2019-10-11.

## Product

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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-0507-2020
- **Recalling firm:** Nucryo Vascular Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-11
- **Report date:** 2019-11-27
- **Termination date:** 2021-05-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0507-2020

## Citation

> AI Analytics. FDA recall Z-0507-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0507-2020. Source: US FDA. Licensed CC0.

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