Recall Z-1302-2022 ยท OBJ Catheter, Ultrasound, Intravascular
Volcano Corp
Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
| Date | May 13, 2022 |
| Status | Open, Classified |
| Reason | Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications |
| Root cause | Process control |
| Action | On May 25, 2022, Philips issued a "Urgent Medical Device Correction" notification. Phillips asked customers to take the following actions: 1. Philips recommends reviewing the enclosed compliant Instructions for Use, in Appendix A, before proceeding as normal. 2. As per standard practice, precaution should always be used when advancing or removing a catheter in complex vessel anatomies, such as not forcing a catheter into a narrow vessel or a tight stenosis. Vessel calcification, tortuosity and pre-existing untreated vessel spasm are key components to any complex vascular anatomy. Additiona |
| Quantity | 7,520 units |
| 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, F |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153094 | Visions PV .035 Digital IVUS Catheter Volcano Corporation, Dec 31, 2015 |