Quick Facts at a Glance
- Recall Date
- June 24, 2026
- Hazard Level
- HIGH
- Brand
- Medtronic Perfusion Systems
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medtronic Perfusion Systems
- Model numbers
- UDI-DI: 20763000135700, Lot Numbers: 0232602300 0232602383 0232612916 0232680078 0232708967 0232709001 0232910880 0232910881 0232910882 0233077983 0233245850 0233245860 0233245980, UDI-DI: 00763000135706, Lot Numbers: 0232612916 0232709001
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 24, 2026
Reported by FDA DEVICE
August 5, 2026
RecallRadar source check
August 12, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic Perfusion Systems or your healthcare provider for instructions. Notification method: Letter
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Full Description
EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222. Reason: Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.. Classification: Class II. Quantity: 3,621 units. Distribution: Worldwide - US Nationwide distribution.
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Safety Guide
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