Recall Z-1844-2015— Volcano Corporation

Name: FDA recall Z-1844-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-04

Class II · Terminated

Class II FDA medical device recall by Volcano Corporation, initiated 2015-06-04, terminated 2015-10-27. It names one FDA 510(k) clearance: K121273. Product: 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.. Reason: 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.

Recalling firm: Volcano Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-06-04
Terminated: 2015-10-27
Firm location: Rancho Cordova, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K121273 — VISIONS PV .035 DITITAL IVUS CATHETERVolcano Corporation·cleared 2012-09-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.