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Volcano Corp FDA Recalls
6 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 8Class IIJun 13, 2025Reports of IVUS catheter and guide wire entanglement during |
| Philips OmniWire Pressure guide wire REF 89185J PN 300000252891Class IIMay 16, 2022Due to a potential failed sterilization process. |
| Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797Class IIIMay 13, 2022Digital IVUS catheter instructions for use ( IFU) do not con |
| Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797Class IIIMay 13, 2022Digital IVUS catheter instructions for use ( IFU) do not con |
| MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used witClass IIIFeb 3, 2022Multi-Modality Touch Screen Modules (MM-TSM), used with inte |
| IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102Class IIIJan 24, 2022Multi-Modality Touch Screen Modules (MM-TSM), which are beds |