Z-1302-2022Class III

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

Name: Z-1302-2022 Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
Creator: Volcano Corp
Published: 2022-05-13
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2022-05-13 / Open, Classified / root cause: manufacturing process

FDA source

Volcano Corp began a recall of Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797 on 2022-05-13. FDA classified it as Class III and gives the reason as "Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1302-2022
Classification: Class III
Status: Open, Classified
Initiated: 2022-05-13
Posted: 2022-06-29
Recalling firm: Volcano Corporation
Product: Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
Product code: OBJ Catheter, Ultrasound, Intravascular
Reason for recall: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Root cause tag: manufacturing process
FDA 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. 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]
Quantity in commerce: 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, FR, PR, IT, DE, CA, NZ, PL, BR, ZA, NL.
Product codes and lots: All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 ,; UDI/DI: 00845225002596

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1302-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1301-2022	Class III	Ongoing	Voluntary: Firm initiated	2022-07-06	2022-06-29
Z-1302-2022	Class III	Ongoing	Voluntary: Firm initiated	2022-07-06	2022-06-29

Product code OBJ

K153094Class IIVisions PV .035 Digital IVUS CatheterVolcano Corporation / cleared 2015-12-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)