Food, drugs, devices › Medtronic Perfusion Systems
Device recall: DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
FDA enforcement event 97295 is a device recall by Medtronic Perfusion Systems of Brooklyn Park, MN, initiated 6 Aug 2025 and classified Class I, with 3 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 13% of the 945 device enforcement events initiated in 2025 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
"The catheters may not retain their shape."
Distribution
"Worldwide - US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2480-2025 | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113 | 34549 units | Class I | Ongoing | 10 Sep 2025 |
| Z-2481-2025 | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110 | 41200 units | Class I | Ongoing | 10 Sep 2025 |
| Z-2482-2025 | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115 | 25261 units | Class I | Ongoing | 10 Sep 2025 |
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: "The catheters may not retain their shape."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide - US Nationwide distribution."
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.