Venture recall
Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The…
Why was Venture 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
581713 582455 582588 583022 583409 583410 584469 584470 599777 584471 585180 585458 585459 585787 586408 586972 587035 587036 587408 587775 588097 588098 588099 588100 588794 589268 589754 589885 589886 590172 590404 590562 590776 591196 591197 591198 592080 592081 592526 592924 593080 593519 593520 593720 594204 594421 595195 595196 595418 595419 596020 597293 597294 597771 597905 597967 598903 599045 599466 599650 599903 601196 601745 601746 602260 603987 603988 603990 603991 604049 604500 604862 605617
- Product
- Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The…
- Recalling firm
- Vascular Solutions, Inc.
- Quantity
- 13,551 (7,054 are unexpired)
- Distribution
- 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.
- Recall date
- June 28, 2017
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)