Recall Z-0726-2019 ยท OBJ Catheter, Ultrasound, Intravascular
Volcano Corporation
Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information
| Date | Oct 17, 2018 |
| Status | Terminated |
| Reason | Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter. |
| Root cause | Under Investigation by firm |
| Action | The firm disseminated a Medical Device Advisory Notice by mail on 10/17/2018. The letter requested that the consignee notify the complaint department at 800-228-4728 Option 3 or email IGTD.CustomerInquiry@philips.com to report an ability to insert the guidewire into the catheter. The defective units will be replaced. |
| Quantity | 6870 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121273 | VISIONS PV .035 DITITAL IVUS CATHETER Volcano Corporation, Sep 10, 2012 |