Product Safety Recalls

Product Recall Tracker

Volcano Corp Recall 90252

Description: Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797

Volcano Corp Recall 90252 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1301-2022
Event ID90252
Event DescriptionVolcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Product TypeDevices
DistributionWorldwide 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.
Quantity14.031 units
Recall ReasonDigital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Device Classification20220706
Device Code InfoAll Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 , ; UDI/DI: 00845225002329
Center Classification Date20220629
Recall Initiation Date20220513
Recalling FirmVolcano Corp
Initial Notification Letter
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.