Medtronic EOPA Arterial Cannula Recall for Leak Risk
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Medtronic Perfusion Systems is recalling 21,290 units of EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR due to potential pinhole leaks.
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 the EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR because pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass.
Which Products Are Affected
The affected product is the EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, Model Number 77422, intended for use with cardiopulmonary bypass as an arterial return cannula. It includes UDI-DI 20763000135632 (Lot Numbers: 0232446429, 0232446444, 0232486752, 0232601515, 0232601516, 0232601522, 0232601586, 0232601591, 0232601593, 0232602180, 0232798265, 0232798353, 0232849583, 0232894981, 0232895082, 0232902694, 0232902697, 0232902698, 0232902700, 0232902803, 0232902805, 0232902846, 0232985469, 0233009922, 0233108251, 0233116991, 0233127352, 0233334923, 0233334966, 0233426694, 0233426695, 0233528727) and UDI-DI 00763000135638 (Lot Numbers: 0232446444, 0232798353, 0232895082, 0232902697, 0232902803, 0232902846, 0232985469, 0233127352, 0233334923). A total of 21,290 units were distributed nationwide in the United States and worldwide.
What You Should Do
Stop using affected products and contact the recalling firm regarding return or refund procedures.
Why This Matters
Potential risks associated with pinhole leaks include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
Source
FDA Recall Number Z-2806-2026, 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 (1,452 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.