Digital IVUS Catheter Recalled for Missing Contraindication Information
Volcano Corp is recalling 7,520 units of the Volcano Visions PV. 035 Digital IVUS Catheter due to missing contraindication information in the instructions for use. The IFU lacks details about situations where the device should not be used.
- Product
- Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
- Category
- Medical Device
- Distribution
- Distributed nationwide