Medtronic GUNDRY Retrograde Cannula
Medtronic recalls GUNDRY Retrograde Cannula 13FR over sterile barrier breach risk.
Stop using the recalled cannula immediately. Contact Medtronic Perfusion Systems for instructions on returning the product and obtaining a replacement.
Why it was recalled
Medtronic Perfusion Systems is recalling certain lots of the GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T, due to a potential sterile barrier breach that could compromise sterility and pose a 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.
| Product | UPC | Recall # |
|---|---|---|
| Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter | 00643169454736, 0231650787, 0231758255, 0231862812, 00673978188713, 0231937422, 20643169454730, 0231650787, 0231650793, 0231758250, 0231758255, 0231758279, 0231758282, 0231823523, 0231862812, 0231937422 | Z-2218-2026 |
| Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter | 20643169454785, 0231757977, 0231757978, 0231757985, 0231758246, 0231758249, 0231758254, 0231758262, 0231772525, 0231792898, 0232066774, 0232112345, 0232114667 | Z-2219-2026 |
| Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter | 20643169454556, 0231881762, 0231881786, 0231931962, 0231962106 | Z-2216-2026 |
| Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter | 00673978188447, 0231651336, 20643169454877, 0231651336, 0231651345, 0231651385, 0231651389, 0231651396, 0231667029, 0231667046, 0231757975, 0231758248, 0231758259, 0231936467, 0231982226, 0232274424 | Z-2214-2026 |
| Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter | 20643169454808, 0231859673 | Z-2221-2026 |
| Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter | 00643169454705, 0231823435, 0231961203, 20643169454709, 0231823435, 0231823478, 0231961203 | Z-2217-2026 |
| Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter | 20643169454815, 0231665658 | Z-2222-2026 |
| Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter | 00643169454460, 0231665646, 20643169454464, 0231665646, 0231665648 | Z-2220-2026 |
| Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter | 00643169454521, 0231545565, 20643169454525, 0231545557, 0231545560, 0231545565, 0231545567, 0231545569, 0231592142, 0231592228, 0231592241, 0231665664, 0231665707, 0231665708, 0231665711, 0231665712, 0231665713, 0231665714, 0231665715, 0231665716 | Z-2215-2026 |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Medtronic Perfusion Systems
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification