Recall Z-0726-2019— Volcano Corporation

Name: FDA recall Z-0726-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-17

Class II · Terminated

Class II FDA medical device recall by Volcano Corporation, initiated 2018-10-17, terminated 2021-04-30. It names one FDA 510(k) clearance: K121273. Product: Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices.. Reason: Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter..

Recalling firm: Volcano Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-10-17
Terminated: 2021-04-30
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

Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices.

Reason for recall

Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.

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