| 2025-06-13 |
Class II
|
Ongoing |
Z-2221-2025 |
Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 8… |
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Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide cathete… |
| 2022-05-16 |
Class II
|
Terminated |
Z-1270-2022 |
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 |
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Due to a potential failed sterilization process. |
| 2022-05-13 |
Class III
|
Ongoing |
Z-1302-2022 |
Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797 |
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Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications |
| 2022-05-13 |
Class III
|
Ongoing |
Z-1301-2022 |
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797 |
— |
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications |
| 2022-02-03 |
Class III
|
Ongoing |
Z-0917-2022 |
MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used wit… |
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Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could beco… |
| 2022-01-24 |
Class III
|
Ongoing |
Z-0901-2022 |
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102 |
— |
Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling… |
| 2022-01-19 |
Class II
|
Ongoing |
Z-0885-2022 |
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x |
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If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registrati… |