Medtronic EOPA Arterial Cannula Recall Issued
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Medtronic Perfusion Systems is recalling 13,510 units of EOPA Elongated One-Piece Arterial Cannula model 77622 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, medical-devices.
What Happened
Medtronic Perfusion Systems initiated a voluntary recall of the EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR after determining that 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 Elongated One-Piece Arterial Cannula DIL TIP 22FR, Model Number 77622, UDI-DI 20763000135670. A total of 13,510 units are affected, distributed worldwide with US nationwide distribution. Affected lot numbers include: 0232601501, 0232601510, 0232601549, 0232601550, 0232602178, 0232602290, 0232602302, 0232910952, 0232910953, 0232910954, 0232910955, 0233244075, 0233244301, 0233244531, 0233286362, 0233286374, 0233286390, 0233409034, 0233416071, 0233528731. The recall number is Z-2808-2026 and it is classified as Class II.
What You Should Do
Consumers and healthcare facilities should follow instructions provided by Medtronic Perfusion Systems regarding the recalled devices. Contact the recalling firm for return or replacement information.
Why This Matters
The recall affects devices used in cardiopulmonary bypass procedures across the United States and worldwide, with risks that may lead to adverse health consequences.
Source
FDA recall number Z-2808-2026, Medtronic Perfusion Systems, Brooklyn Park, MN.
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 (1,437 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.