Class II — Vascular Solutions, Inc.
| Recalling firm | Vascular Solutions LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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 |
| Quantity | 4731 |
| Distribution | Worldwide Distribution - USA Nationwide including the states of AL, AZ, AR, CA, CO, CT, DE, CD, FL, GA, HI, ID, IL ,IN, IA, KY, LA, ME, MD, MA, MI,MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT VA, WA, WV, WI, WY and AUSTRIA, CANDA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, ISRAEL,. ITALY, MEXICO, NETHERLANDS, NORWAY, SPAIN, SWEDEN, SWITZERLAND, TAIWAN… |
| Initiated | 2013-01-29 |
| Classified | 2013-02-20 |
| Terminated | 2013-06-25 |
| Recall number | Z-0868-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Vascular Solutions, Inc. (Z-0868-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64215/
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