PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 26, 2015 Initiated: July 24, 2015 #Z-2420-2015

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.

Details

Units Affected
221 (111 US, 110 OUS)
Distribution
Worldwide distribution. US nationwide including: FL, GA, IL, MI, NY, NC, PA, WV; Germany, Hong Kong, and Italy.
Location
Brooklyn Park, MN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Medtronic Perfusion Systems. Units affected: 221 (111 US, 110 OUS).
Why was this product recalled?
EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 26, 2015. Severity: Moderate. Recall number: Z-2420-2015.