The PolarCath Balloon Catheter consists of a coaxial catheter shaft… — Class II medical device recall Z-0507-2020
Terminated recall by Nucryo Vascular Inc., reported 2019-11-27, distributed in AR, CA, MI, MS, OK, TX. Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized lab
| Recall number | Z-0507-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nucryo Vascular Inc., San Jose, CA, United States |
| Recall initiated | 2019-10-11 |
| Classified | 2019-11-21 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2021-05-03 |
| Distributed | AR, CA, MI, MS, OK, TX |
| Quantity | 49 |
| Reason classes | labeling |
| Lot numbers | 0738, 0739, 0740, 0743, 0744, 0746, 0750, 0751, 0758 |
| Model numbers | 0738, 0739, 0740, 0743, 0744, 0746, 0750, 0751, 0758 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0507-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.