Recall Z-1775-2017 ยท OBJ Catheter, Ultrasound, Intravascular
Volcano Corporation
Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventiona
| Date | Apr 10, 2017 (initiated Mar 29, 2017) |
| Status | Terminated |
| Reason | High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging. |
| Root cause | Under Investigation by firm |
| Action | Recall letters dated March 28, 2017 will be hand delivered by Volcano reps. Reps will also pick up any unused catheters for return and obtain a signed proof of delivery for both customer and Volcano Rep. |
| Quantity | 718 total units |
| Distribution | Distribution to US and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip Volcano Corporation, Oct 26, 2016 |