Device 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.
Z-2420-2015
Product summary
- Event
- Event 71897
- Status
- Terminated
- Classification
- Class II
- Quantity
- 221 (111 US, 110 OUS)
- Official record key
device-enforcement:Z-2420-2015
Official wording
Reason: EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.
Code information: Lot number 2015060544;
Distribution pattern: Worldwide distribution. US nationwide including: FL, GA, IL, MI, NY, NC, PA, WV; Germany, Hong Kong, and Italy.
Derived failure modes
-
Unknown
EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.