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.
- Company
- Volcano Corporation
- Recall Initiated
- March 29, 2017
- Posted
- April 10, 2017
- Terminated
- June 21, 2017
- Recall Number
- Z-1776-2017
- Quantity
- 718 total devices
- Firm Location
- Rancho Cordova, CA
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.
Distribution
Distribution to US and Japan
Lot / Code Info
Lot # 50069132, Expiry date 6/30/2018; Lot # 50083527, Expiry date 11/30/2018; Lot # 50083533, Expiry Date 11/30/2018.
Root 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.
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