Z-1776-2017 Class II Terminated
FDA device recall Z-1776-2017 was initiated by Volcano Corporation on March 29, 2017 and is designated Class II. 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. The recall status is terminated (terminated June 21, 2017). Affected quantity: 718 total devices.
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2017
- Initiation Date
- March 29, 2017
- Termination Date
- June 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 718 total devices
Product Description
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.
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 Pattern
Distribution to US and Japan
Code Information
Lot # 50069132, Expiry date 6/30/2018; Lot # 50083527, Expiry date 11/30/2018; Lot # 50083533, Expiry Date 11/30/2018.