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
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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/ Manufacturer |
Volcano Corporation 2870 Kilgore Rd Rancho Cordova CA 95670-6133
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = OBJ
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