Recall Z-2420-2015— Medtronic Perfusion Systems

Name: FDA recall Z-2420-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-24

Class II · Terminated

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2015-07-24, terminated 2016-04-04. It names one FDA 510(k) clearance: K031037. Product: Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.. Reason: EOPA Arterial Cannula Devices in this lot were shipped without the guidewire..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Terminated
Initiated: 2015-07-24
Terminated: 2016-04-04
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K031037 — EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIREMedtronic Perfusion Systems·cleared 2003-05-13

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

Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.

Reason for recall

EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.

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