Food, drugs, devices › Medtronic Perfusion Systems
Device recall: Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP¿ C
FDA enforcement event 94274 is a device recall by Medtronic Perfusion Systems of Brooklyn Park, MN, initiated 19 Mar 2024 and classified Class II, with 13 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 970 device enforcement events initiated in 2024 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
"Potential for unsealed sterile packing."
Distribution
"Worldwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1793-2024 | Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220; c) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 82020; d) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number… | 13033 units | Class II | Ongoing | 22 May 2024 |
| Z-1794-2024 | Medtronic Clearview Blower/Mister, Model Number 22120 | 500 units | Class II | Ongoing | 22 May 2024 |
| Z-1795-2024 | Medtronic DLP Coronary Ostial Cannulae, Model Number 30050 | 250 units | Class II | Ongoing | 22 May 2024 |
| Z-1796-2024 | Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001 | 7935 units | Class II | Ongoing | 22 May 2024 |
| Z-1797-2024 | Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001, d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113, e) DLP¿ Left Heart Vent Catheter 16 Fr.,… | 13954 units | Class II | Ongoing | 22 May 2024 |
| Z-1798-2024 | Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourniquet Kit, Model Number 79009 | 1760 units | Class II | Ongoing | 22 May 2024 |
| Z-1799-2024 | Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Blunt Tip, Model Number 30003 | 5719 units | Class II | Ongoing | 22 May 2024 |
| Z-1800-2024 | Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L | 2622 units | Class II | Ongoing | 22 May 2024 |
| Z-1801-2024 | Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010, c) DLP¿ 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003, d) DLP¿ 38.1 cm (15 in) Multiple Perfusion Set,… | 6290 units | Class II | Ongoing | 22 May 2024 |
| Z-1802-2024 | Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000 | 1624 units | Class II | Ongoing | 22 May 2024 |
| Z-1803-2024 | Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers: 31200 | 1410 units | Class II | Ongoing | 22 May 2024 |
| Z-1804-2024 | Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP¿ Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10052, c) DLP¿ Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10053, d) DLP¿ Suction Tube 10 Fr. Shaft with 20 Fr. Pool Tip, Model Number:… | 13198 units | Class II | Ongoing | 22 May 2024 |
| Z-1805-2024 | Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP¿ 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP¿ 30 Fr. Malleable Single Stage Venous Cannula, Model Number… | 17221 units | Class II | Ongoing | 22 May 2024 |
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: "Potential for unsealed sterile packing."
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."
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.