Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
Check against the official notice below — it lists the full affected range.
Volcano Corp is recalling the Volcano Visions PV. 035 Digital IVUS Catheter (REF 81234, PN: 300007367341) because the instructions for use do not contain contraindications. The recall affects 7,520 units distributed worldwide, including widespread distribution across the United States and multiple international countries including Spain, Sweden, France, Italy, Germany, Canada, New Zealand, Poland, Brazil, and South Africa. The affected products are all lots containing IFU Part Number 300004856772/A with a revision date of 05/2021.
The recall record does not specify a remedy or what affected consumers should do in response to this recall.
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: 7,520 units Lot/code info: All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 ,; UDI/DI: 00845225002596
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.