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.
FDA Recall Z-0507-2020 · Posted None
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Recalling FirmNucryo Vascular Inc.
Recall StatusTerminated
Product CodeLIT
Date Initiated2019-10-11
Date Terminated2021-05-03
Product Quantity49
Reason for Recall
Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.
Firm Action
On 10/11/19, Field Advisory Notices were mailed to customers informing them to check their inventory and return affected unused product. Further, customers were asked to complete and return the Field Action Response form. Customer service can be contacted at the following number , 408-541-1414.
Root Cause
Error in labeling
Distribution Pattern
U.S.: CA, TX, OK, AR, MI, MS. No foreign (OUS) distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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