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
- Recalling Firm
- Medtronic Perfusion Systems
- 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.
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