Recall Z-2718-2015— Volcano Corporation

Name: FDA recall Z-2718-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-22

Class II · Terminated

Class II FDA medical device recall by Volcano Corporation, initiated 2015-07-22, terminated 2016-04-28. It names 2 FDA 510(k) clearances: K101777, K081804. Product: Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature.. Reason: Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Catheters..

Recalling firm: Volcano Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-07-22
Terminated: 2016-04-28
Firm location: Rancho Cordova, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K101777 — PIONEER PLUS CATHETER, MODEL PLUS 120Medtronic Vascular·cleared 2010-07-23
K081804 — PIONEER PLUS CATHETERMedtronic, Inc.·cleared 2008-08-05

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 Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature.

Reason for recall

Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Catheters.

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