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U.S. Department of Health and Human Services

Class 2 Device Recall REFINITY

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  Class 2 Device Recall REFINITY see related information
Date Initiated by Firm March 29, 2017
Date Posted April 10, 2017
Recall Status1 Terminated 3 on June 21, 2017
Recall Number Z-1775-2017
Recall Event ID 76885
510(K)Number K160583  
Product Classification Catheter, ultrasound, intravascular - Product Code OBJ
Product 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 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.
Code Information Lot # 50068951, Expiry date 06/30/2018; Lot # 50068952, Expiry date 06/30/2018; Lot # 50069133, Expiry date 06/30/2018; Lot # 50083387, Expiry Date 11/30/2018; Lot # 50083390, Expiry Date 11/30/2018.
Recalling Firm/
Volcano Corporation
2870 Kilgore Rd
Rancho Cordova CA 95670-6133
Manufacturer 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 2
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 in Commerce 718 total units
Distribution Distribution to US and Japan
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OBJ and Original Applicant = VOLCANO CORPORATION