Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The PolarCath Balloon Catheter consists of a coaxial catheter shaft Recalled by Nucryo Vascular Inc. Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nucryo Vascular Inc. directly.
Affected Products
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.
Quantity: 49
Why Was This Recalled?
Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.
Where Was This Sold?
This product was distributed to 6 states: AR, CA, MI, MS, OK, TX
About Nucryo Vascular Inc.
Nucryo Vascular Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report