Z-2420-2015 Class II Terminated
FDA device recall Z-2420-2015 was initiated by Medtronic Perfusion Systems on Jul 24, 2015 and is designated Class II. Reason for recall: EOPA Arterial Cannula Devices in this lot were shipped without the guidewire. The recall status is terminated (terminated Apr 4, 2016). Affected quantity: 221 (111 US, 110 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Aug 26, 2015
- Initiation Date
- Jul 24, 2015
- Termination Date
- Apr 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 221 (111 US, 110 OUS)
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.
Distribution Pattern
Worldwide distribution. US nationwide including: FL, GA, IL, MI, NY, NC, PA, WV; Germany, Hong Kong, and Italy.
Code Information
Lot number 2015060544;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2420-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026