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Open, Classified

Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797

FDA Recall Z-1302-2022 · Posted None

Recalling FirmVolcano Corp
Recall StatusOpen, Classified
Product CodeOBJ
Date Initiated2022-05-13
Product Quantity7,520 units

Reason for Recall

Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications

Firm 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. 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: [email protected]

Root Cause

Process control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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