Recall Z-0507-2020 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Nucryo Vascular Inc.
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 bal
| Date | Oct 11, 2019 |
| Status | Terminated |
| Reason | Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels. |
| Root cause | Error in labeling |
| 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. |
| Quantity | 49 |
| Distribution | U.S.: CA, TX, OK, AR, MI, MS. No foreign (OUS) distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152665 | PolarCath Peripheral Dilatation System Nucyro Vascular, LLC, Oct 26, 2015 |