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
  • 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
  • 1 Event

Manufacturer

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

One device with a similar name

Learn more about the data here

  • 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
  • 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