Medtronic GUNDRY Retrograde Cannula Recall Issued

Source: FDA · Worldwide

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Medtronic Perfusion Systems is recalling 6,572 units of GUNDRY Retrograde Cannula due to potential sterile barrier breach in certain lots.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on June 11, 2026 and geographically references Worldwide. 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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What Happened Medtronic Perfusion Systems initiated a voluntary recall of specific lots of the Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR after determining that certain lots have the potential for a sterile barrier breach.

Which Products Are Affected The recall covers the Medtronic GUNDRY Retrograde Cannula, Model 94115T (Cardiopulmonary bypass vascular catheter). Affected units total 6,572 and include GTIN 00643169454521 (Lot Numbers: 0231545565, C231958117) and GTIN 20643169454525 (Lot Numbers: 0231545557, 0231545560, 0231545565, 0231545567, 0231545569, 0231592142, 0231592228, 0231592241, 0231665664, 0231665707, 0231665708, 0231665711, 0231665712, 0231665713, 0231665714, 0231665715, 0231665716, 0231667178, 0231823613, 0231823689, 0231823700, 0231846134, 0231862819, 0231912810, C231958117, C231958118, C231958119, C231958120, C232287623). Distribution was worldwide, including US nationwide.

What You Should Do Consumers and facilities should check inventory for the listed lot numbers and contact Medtronic Perfusion Systems for return or further instructions.

Why This Matters The Class II recall addresses a potential compromise in product sterility for a device used in cardiopulmonary bypass procedures.

Source FDA recall number Z-2215-2026, event ID 98786.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medtronic Perfusion Systems is recalling 6,572 units of GUNDRY Retrograde Cannula due to potential sterile barrier breach in certain lots.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Worldwide. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.