Medtronic EOPA Arterial Cannula Recalled for Missing Guidewire
Medtronic is recalling EOPA Arterial Cannulas (Lot 2015060544) because they were shipped without the required guidewire.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that no illnesses or injuries have been reported. The hazard is a missing component (guidewire) rather than a high-risk pathogen or structural defect causing immediate harm, fitting the criteria for a moderate severity score.
Plain-English summary
Medtronic Perfusion Systems is recalling the EOPA Arterial Cannula, Model # 77620, Lot 2015060544. The recall was initiated because the devices in this specific lot were shipped without the guidewire. The product is intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.
A total of 221 units were distributed worldwide, including 111 units in the United States and 110 units outside the US. US distribution included Florida, Georgia, Illinois, Michigan, New York, North Carolina, Pennsylvania, and West Virginia. International distribution included Germany, Hong Kong, and Italy.
This is a Class II recall. The FDA has not reported any illnesses or injuries associated with this recall. Healthcare facilities should stop using the affected devices and contact Medtronic Perfusion Systems for further instructions.
The recalled product
- 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.
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device — Cardiovascular
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number 2015060544
Distribution
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