Recall Z-1776-2017
Volcano Corporation · initiated March 29, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.273; Catalog number 89900. 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 interventional procedures. REFINITY (or REFINITY ST) catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
Codes / lots: Lot # 50069132, Expiry date 6/30/2018; Lot # 50083527, Expiry date 11/30/2018; Lot # 50083533, Expiry Date 11/30/2018.
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.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-1776-2017
- Initiated
- March 29, 2017
- Posted by FDA
- April 10, 2017
- Terminated
- June 21, 2017
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Quantity
- 718 total devices
- Distribution
- Distribution to US and Japan
- Recalling firm
- Volcano Corporation, Rancho Cordova, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1775-2017 Class II | Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number:…High complaint rates of kinking near the junction of the proximal shaft to telescope section of the… | 03/29/2017Terminated |