Device 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.
Z-1775-2017
Product summary
- Event
- Event 76885
- Status
- Terminated
- Classification
- Class II
- Quantity
- 718 total units
- Official record key
device-enforcement:Z-1775-2017
Official wording
Reason: 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.
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.
Distribution pattern: Distribution to US and Japan
Derived failure modes
-
Unknown
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.