FDA Device recall Z-1302-2022
Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
- FDA Device
- Class III
- ongoing
- Published 2022-07-06
On 2022-07-06 the FDA classified a Class III recall of Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797 by Volcano, citing digital IVUS catheter instructions for use ( IFU) do not contain contrainidications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1302-2022 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2022-05-13 |
| Published | 2022-07-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Volcano |
| Distribution | US |
Product
Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
Reason
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Identifiers
| code_info | All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 ,; UDI/DI: 00845225002596 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Volcano
- Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
FDA Device · Class II · 2026-10-07 · Volcano - Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P
FDA Device · Class II · 2025-08-06 · Volcano - Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
FDA Device · Class III · 2022-07-06 · Volcano - Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
FDA Device · Class II · 2022-06-22 · Volcano - IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
FDA Device · Class III · 2022-04-20 · Volcano
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1302-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.