Venture RX Catheter — Class I medical device recall Z-2224-2017
Terminated recall by Vascular Solutions, Inc., reported 2017-06-28, distributed nationwide. Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential proble
| Recall number | Z-2224-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vascular Solutions, Inc., Maple Grove, MN, United States |
| Recall initiated | 2017-04-25 |
| Classified | 2017-06-20 |
| Reported by FDA | 2017-06-28 |
| Terminated | 2019-11-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CZ, DE, EG, ES, FI, FR, GB, GR, HK, IE, IL, IT, LB, NL, NO, PL, RU, SA, SE, TR, ZA |
| Reason classes | device malfunction |
| Model numbers | 5820, 5821, 5822 |
Product
Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW versions (Models 5821 and 5822) may also be used for manual delivery of saline solution or diagnostic contrast agents
Reason for recall
Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential problem. Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model 5822) catheters. After an internal investigation, VSI determined that material used in catheter construction may detach from within the lumen of the distal tip during use.
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-2224-2017. 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.