Vascular Solutions — Class II medical device recall Z-0868-2013
Terminated recall by Vascular Solutions, Inc., reported 2013-02-27, distributed nationwide. Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters.
| Recall number | Z-0868-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vascular Solutions, Inc., Maple Grove, MN, United States |
| Recall initiated | 2013-01-29 |
| Classified | 2013-02-20 |
| Reported by FDA | 2013-02-27 |
| Terminated | 2013-06-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, DE, DK, ES, FI, FR, GB, GR, HU, IL, IT, MX, NL, NO, SE, TR, TW |
| Quantity | 4,731 |
| Model numbers | 5300, 5307, 5324, 5325, 5329, 5332, 5336, 5340, 5341 |
Product
Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341. Product Usage: The SuperCross catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents
Reason for recall
Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing.
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-0868-2013. 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.