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 12115 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-2482-2025
- 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 12115 LV VENT 15FR, Model Number 12115
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: 20643169880935, 00643169880931, 00681490463423; Serial Numbers: 2023051189 2023060145 2023060432 2023061147 2023070491 2023070980 2023080157 2023080407 2023080408 2023080799 2023080800 2023081133 2023081134 2023081549 2023090236 2023090429 2023091017 2023091107 2023091108 2023100097 2023100098 2023100098 2023100643 2023100644 2023101026 2023101027 2023101367 2023101367 2023101368 2023110168 2023111663 2023111663 2023111663 2023111700 2023111701 2023111702 2023111703 2023111703 2023120176 2023120177 2023120178 2023120179 2023120719 2023120719 2023121046 2023121046 2023121256 2024010194 2024010195 2024010196 2024010197 2024010198 2024010199 2024010200 2024010201 2024010202 2024010202 2024011215 2024011216 2024011216 2024011217 2024011218 2024011219 2024011219 2024011220 2024011221 2024011221 2024030367 2024030367 2024030368 2024030368 2024030841 2024030842 202307C113 202308C250 202309C023 202311C008 202311C009 202312C206 202312C207 202312C208 202401C008 202402C088 202403C101 202403C102 202406C058
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 6,212| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Cardioroot Woven Collagen Coated Vascular Graft recalled | SAS Intervascular | Other | Nationwide |
| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |