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Medtronic GUNDRY Retrograde Cannula
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MEDICAL DEVICE RECALLMODERATE

Medtronic GUNDRY Retrograde Cannula

Medtronic recalls GUNDRY Retrograde Cannula over sterile barrier breach risk.

What to do

Check the model number on your product to see if it is affected. If you have Model 94113T, stop using it immediately and contact Medtronic for instructions on returning the product and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-2214-2026
Agency
FDA
Firm
Medtronic Perfusion Systems
Recall ID
98786
Status
ONGOING

Why it was recalled

Medtronic Perfusion Systems is recalling the GUNDRY Retrograde Cannula, a cardiopulmonary bypass vascular catheter, because certain lots may have a sterile barrier breach, which could compromise sterility and increase the risk of infection.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeRecall #UDI-DI
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter0231650787, 0231758255, 0231862812, C231966207, 0231937422, 0231650793, 0231758250, 0231758279, 0231758282, 0231823523, C231965721, C232428221, C232430086Z-2218-202600643169454736, 0231650787, 0231758255, 0231862812, 00673978188713, 0231937422, 20643169454730, 0231650787, 0231650793, 0231758250, 0231758255, 0231758279, 0231758282, 0231823523, 0231862812, 0231937422
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter0231757977, 0231757978, 0231757985, 0231758246, 0231758249, 0231758254, 0231758262, 0231772525, 0231792898, 0232066774, 0232112345, 0232114667, C232276641, C232277146, C232277149, C232949860, C232949864Z-2219-202620643169454785, 0231757977, 0231757978, 0231757985, 0231758246, 0231758249, 0231758254, 0231758262, 0231772525, 0231792898, 0232066774, 0232112345, 0232114667
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter0231881762, 0231881786, 0231931962, 0231962106, C233032040Z-2216-202620643169454556, 0231881762, 0231881786, 0231931962, 0231962106
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter0231651336, 0231651345, 0231651385, 0231651389, 0231651396, 0231667029, 0231667046, 0231757975, 0231758248, 0231758259, 0231936467, 0231982226, 0232274424, C232287618, C232287619, C232287620, C232598550, C232598552Z-2214-202600673978188447, 0231651336, 20643169454877, 0231651336, 0231651345, 0231651385, 0231651389, 0231651396, 0231667029, 0231667046, 0231757975, 0231758248, 0231758259, 0231936467, 0231982226, 0232274424
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter0231859673Z-2221-202620643169454808, 0231859673
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter0231823435, 0231961203, 0231823478Z-2217-202600643169454705, 0231823435, 0231961203, 20643169454709, 0231823435, 0231823478, 0231961203
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter0231665658, C231786900Z-2222-202620643169454815, 0231665658
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter0231665646, 0231665648Z-2220-202600643169454460, 0231665646, 20643169454464, 0231665646, 0231665648
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter0231545565, C231958117, 0231545557, 0231545560, 0231545567, 0231545569, 0231592142, 0231592228, 0231592241, 0231665664, 0231665707, 0231665708, 0231665711, 0231665712, 0231665713, 0231665714, 0231665715, 0231665716, 0231667178, 0231823613, 0231823689, 0231823700, 0231846134, 0231862819, 0231912810, C231958118, C231958119, C231958120, C232287623Z-2215-202600643169454521, 0231545565, 20643169454525, 0231545557, 0231545560, 0231545565, 0231545567, 0231545569, 0231592142, 0231592228, 0231592241, 0231665664, 0231665707, 0231665708, 0231665711, 0231665712, 0231665713, 0231665714, 0231665715, 0231665716

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other recent recalls from Medtronic Perfusion Systems

All recalls from Medtronic Perfusion Systems

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Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification