CLASS I ONGOING Device recall · Reported 10 Sep 2025 · FDA Enforcement Report
Dlp Left Heart Vent Catheter Malleable body recalled
Medtronic Perfusion Systems is recalling Dlp Left Heart Vent Catheter Malleable body and vented connector, Suction 12113 LV Vent, distributed nationwide in the US. The recall was initiated on 6 Aug 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2480-2025
- FDA event ID
- 97295
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 6 Aug 2025
- FDA classified
- 3 Sep 2025
- Reported
- 10 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 6 Aug 2025 | Recall initiated by company | |
| 3 Sep 2025 | Classified by FDA | +28 days |
| 10 Sep 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The catheters may not retain their shape.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Why was it recalled?
The catheters may not retain their shape.
Which lots are affected?
UDI-DI: 20643169881338, 00673978176475, 00643169881334; Serial Numbers: 2023051188 2023060142 2023060144 2023060431 2023060762 2023061146 2023061146 2023070147 2023070147 2023070148 2023070148 2023070149 2023070149 2023070150 2023070150 2023070151 2023070490 2023070490 2023070979 2023080156 2023080797 2023080798 2023080798 2023081130 2023081131 2023081131 2023081132 2023081547 2023081548 2023081548 2023090234 2023090235 2023090427 2023090675 2023090979 2023090980 2023091104 2023091105 2023091105 2023091106 2023091106 2023100243 2023100243 2023100244 2023100641 2023100641 2023100642 2023101024 2023101025 2023101025 2023101365 2023101365 2023101366 2023110247 2023110308 2023110308 2023110312 2023110312 2023121249 2023121250 2023121250 2023121251 2023121251 2023121251 2023121252 2023121253 2023121254 2023121255 2024010470 2024010471 2024010472 2024010472 2024010473 2024010474 2024010474 2024010475 2024010475 2024010476 2024010476 2024010477 2024011016 2024011016 2024011214 2024031093 2024031094 2024031095 2024040067 2024040068 2024040068 2024040069 2024040070 2024040071 2024040245 2024040245 2024060793 202307C112 202308C248 202308C249 202309C022 202310C057 202310C058 202312C203 202402C086 202403C085 202403C086 202403C087 202406C057 202407C109
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 97295This product is part of a recall event; the main page for the event is Dlp Left Heart Vent Catheter Malleable body recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Dlp Left Heart Vent Catheter Malleable body recalled | Medtronic Perfusion Systems | Device Malfunction | Nationwide | |
| CLASS I | Dlp Left Heart Vent Catheter Malleable body recalled | Medtronic Perfusion Systems | Device Malfunction | Nationwide |
More recalls from Medtronic Perfusion Systems
All 116| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Eopa Elongated One-Piece Arterial Cannula Blunt recalled | Medtronic Perfusion Systems | Packaging Defects | Nationwide |
| Device | CLASS II | EOPA Elongated One-Piece Arterial Cannula DIL TIP recalled | Medtronic Perfusion Systems | Packaging Defects | Nationwide |
| Device | CLASS II | Eopa Elongated One-Piece Arterial Cannula Blunt recalled | Medtronic Perfusion Systems | Packaging Defects | Nationwide |
| Device | CLASS II | EOPA 3D Arterial Cannula DIL TIP, intended for use recalled | Medtronic Perfusion Systems | Packaging Defects | Nationwide |
| Device | CLASS II | EOPA 3D Arterial Cannula, intended for use recalled | Medtronic Perfusion Systems | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |