Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Summary
The FDA issued a Class III for Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Onl by Volcano Corp. Reason: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications.
Details
Source
Device Recall
External ID
Z-1301-2022
Action Date
2022-07-06
Status
Ongoing
Category
device
Product Description
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Lot/Code Info: All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 , ; UDI/DI: 00845225002329
Quantity Affected: 14.031 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-13
Company
San Diego, CA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Volcano Corp has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Volcano Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Volcano Corp have FDA actions?
Volcano Corp has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1301-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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