Medtronic EOPA 3D Arterial Cannula Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Medtronic is recalling 3,621 units of the EOPA 3D Arterial Cannula due to potential pinhole leaks during use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 13, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Medtronic Perfusion Systems is recalling certain EOPA 3D Arterial Cannula units because pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
Which Products Are Affected
The recall covers the EOPA 3D Arterial Cannula DIL TIP 22FR (Model Number 78222), intended for use with cardiopulmonary bypass as an arterial return cannula. A total of 3,621 units are affected. Affected lot numbers are listed under UDI-DI 20763000135700 and UDI-DI 00763000135706. Distribution was US Nationwide and worldwide.
What You Should Do
Consumers should follow instructions provided in the firm's notification letter for returns or further guidance. Contact Medtronic Perfusion Systems for recall-related information.
Why This Matters
The recall addresses a device defect that could lead to serious complications during cardiopulmonary bypass procedures.
Source
FDA recall number Z-2810-2026, Class II, event ID 99320.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,072 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.