Medtronic EOPA Arterial Cannula Recall
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Medtronic Perfusion Systems is recalling 11,720 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, medical-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. Potential risks include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
Which Products Are Affected
The recall affects 11,720 units of the EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR (Model Number 77522) distributed nationwide in the United States and worldwide. Affected UDI-DI codes are 00199150023288 (Lot Number: 0233286436) and 20199150023282 (Lot Numbers: 0232709428, 0232744924, 0232745061, 0232745092, 0232798556, 0232862763, 0232862778, 0232862794, 0232862798, 0232903216, 0232903291, 0232903383, 0232990983, 0233286318, 0233286414, 0233286436, 0233427120, 0233528730, 0233553623, 0233556386, 0233585113, 0233585114, 0232670802). The recall number is Z-2807-2026.
What You Should Do
Consumers and healthcare providers should follow instructions provided in the firm's notification letter for handling affected products.
Why This Matters
Class II recalls address situations where use of the device may cause temporary or medically reversible adverse health consequences.
Source
FDA recall number Z-2807-2026, initiated June 24, 2026.
Original source: FDA Official Notice ↗
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