Food, drugs, devices › Medtronic Perfusion Systems
Device recall: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular cat
FDA enforcement event 98786 is a device recall by Medtronic Perfusion Systems of Brooklyn Park, MN, initiated 21 Apr 2026 and classified Class II, with 9 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Medtronic Perfusion Systems has 38 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medtronic Perfusion Systems, Brooklyn Park, MN.
Reason for recall
"Certain lots of product have the potential for a sterile barrier breach."
Distribution
"Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2214-2026 | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter | 3790 units | Class II | Ongoing | 27 May 2026 |
| Z-2215-2026 | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter | 6572 units | Class II | Ongoing | 27 May 2026 |
| Z-2216-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter | 600 units | Class II | Ongoing | 27 May 2026 |
| Z-2217-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter | 840 units | Class II | Ongoing | 27 May 2026 |
| Z-2218-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter | 2620 units | Class II | Ongoing | 27 May 2026 |
| Z-2219-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter | 3210 units | Class II | Ongoing | 27 May 2026 |
| Z-2220-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter | 481 units | Class II | Ongoing | 27 May 2026 |
| Z-2221-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter | 280 units | Class II | Ongoing | 27 May 2026 |
| Z-2222-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter | 260 units | Class II | Ongoing | 27 May 2026 |
Context
Other enforcement events for Medtronic Perfusion Systems
All 38 events for Medtronic Perfusion Systems
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Certain lots of product have the potential for a sterile barrier breach."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.