Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.
Enforcement
- Recall Number
- Z-1844-2015
- Event ID
- 71537
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Volcano Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 1, 2015
- Initiation Date
- June 4, 2015
- Classification Date
- June 25, 2015
- Termination Date
- October 27, 2015
- Address
- 2870 Kilgore Rd, Rancho Cordova, CA, 95670-6133, United States
Description
Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
Product number 88901; lot number 50002518
US Nationwide Distribution and one account in Canada.
162 total devices (included both products)