Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Check against the official notice below — it lists the full affected range.
Volcano Corp has recalled the Volcano Visions PV. 035 Digital IVUS Catheter because the instructions for use do not contain contraindications information. The device was distributed worldwide, including throughout most of the United States as well as in Spain, Sweden, France, Puerto Rico, Italy, Germany, Canada, New Zealand, Poland, Brazil, South Africa, the Netherlands, and other locations. Approximately 14,031 units were affected, specifically those with IFU Part Number 300004856772/A with a Revision Date of May 2021.
The recall notice does not specify a remedy or action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Reason for recall: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications Distribution: Worldwide distribution - US Nationwide distribution in the states of NY, CA, AZ, LA, NV, AL, MI, WI, CO, TX, NJ, OR, FL, KS, IL, MD, PA, OH, NC, OK, MN, AK, GA, MO, SC, MS, KY, AR, VA, SD, TN, MA, DE, NE, MT, CT, WV, WA, IN, IA, HI, NH, WY, UT, ID, DC, RI, NM, ME, VT and the countries of ES, SE, FR, PR, IT, DE, CA, NZ, PL, BR, ZA, NL. Quantity: 14.031 units Lot/code info: All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 , ; UDI/DI: 00845225002329
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.