Devices

Device Recall REFINITY

Model / Serial
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.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distribution to US and Japan
Product Description
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.
Manufacturer
Volcano Corporation
1 Event
- Recall of Device Recall REFINITY

Manufacturer

Volcano Corporation

Manufacturer Address
Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
Manufacturer Parent Company (2017)
Philips
Source
USFDA

One device with a similar name

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Device Recall REFINITY

Model / Serial
Lot # 50069132, Expiry date 6/30/2018; Lot # 50083527, Expiry date 11/30/2018; Lot # 50083533, Expiry Date 11/30/2018.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distribution to US and Japan
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.
Manufacturer
Volcano Corporation

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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