Medtronic EOPA 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 3,110 units of its EOPA Elongated One-Piece 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, medical-devices.
What Happened Medtronic Perfusion Systems is recalling the EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR 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 affects the EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, Model Number 77722. A total of 3,110 units are involved. Affected lot numbers are associated with UDI-DI 20199150023312 (lots: 0232657469, 0232670800, 0232744945, 0232798410, 0232862769, 0232985251, 0233116924, 0233116931) and UDI-DI 00199150023318 (lot: 0232744945). Distribution is US Nationwide and worldwide.
What You Should Do Consumers and healthcare providers should follow the instructions provided in the firm's notification letter for handling the recalled devices.
Why This Matters The recall addresses a manufacturing issue that could compromise device performance during cardiopulmonary bypass procedures.
Source FDA recall number Z-2809-2026, Class II recall initiated June 24, 2026.
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 (1,145 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.