Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardio
FDA device recall Z-1775-2017 · posted 2017-04-10 · Terminated
Recall details
- Recalling firm
- Volcano Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- OBJ
- Quantity affected
- 718 total units
- Distribution
- Distribution to US and Japan
- Date initiated
- 2017-03-29
- Date posted
- 2017-04-10
- Date terminated
- 2017-06-21
- Location
- Rancho Cordova, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip (K160583) | Volcano Corporation | 2016-10-26 |