Class I — 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 I |
| Status | Terminated |
| Reason | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| Product | Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies |
| Quantity | 30,877 units |
| Distribution | Worldwide distribution. US nationwide, Austria, Australia, Belgium, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Slovakia, South Africa, Spain, Sweden, Switzerland, and United Kingdom. |
| Initiated | 2020-03-16 |
| Classified | 2020-04-27 |
| Terminated | 2024-06-18 |
| Recall number | Z-1747-2020 |
| 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 I recall — Vascular Solutions, Inc. (Z-1747-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85350/
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