Recall Z-1301-2022
Volcano Corp · initiated May 13, 2022
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Codes / lots: All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 , ; UDI/DI: 00845225002329
Reason for recall
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
FDA-determined cause: Process control
Action taken
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. Additionally, if the initial guidewire faces resistance or requires further manipulations, please use this as an indicator of complex patient anatomy. 3. Philips is providing this Urgent Medical Device Correction letter to affected customers and recommends forwarding this notification to all staff who need to be aware within your organization or to any organization where the potentially affected devices may have been transferred. 4. To acknowledge receipt of this notification, please complete, sign, and return the Customer Reply Form within 30 days upon receipt of this notice to Email: igtdc.r@philips.com
Details
- Recall number
- Z-1301-2022
- Initiated
- May 13, 2022
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Quantity
- 14.031 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, FR, PR, IT, DE, CA, NZ, PL, BR, ZA, NL.
- Recalling firm
- Volcano Corp, San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1302-2022 Class III | Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only…Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | 05/13/2022Open, Classified |