Recall record at a glance
| Official record | Z-2224-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Vascular Solutions, Inc. |
| Report date | Jun 28, 2017 |
| Recall initiation date | Apr 25, 2017 |
| Quantity | 13,551 (7,054 are unexpired) |
| Location | Maple Grove, MN, United States |
Official product description
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
Why the product was recalled
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.
Distribution information
Worldwide Distribution - US (nationwide): including states of: AK, AL, AR, AZ, CA, CO, CT, DC,FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, ME, MI, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY; and countries of: AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CZECH REPUBLIC, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, IRELAND, ISRAEL, ITALY, LEBANON, NETHERLANDS, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY,and UK.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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