FDA Device recall Z-2480-2025
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
- FDA Device
- Class I
- ongoing
- Published 2025-09-10
On 2025-09-10 the FDA classified a Class I recall of DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113 by Medtronic Perfusion Systems, citing the catheters may not retain their shape.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2480-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-08-06 |
| Published | 2025-09-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | US |
Product
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
Reason
The catheters may not retain their shape.
Identifiers
| code_info | UDI-DI: 20643169881338, 00673978176475, 00643169881334; Serial Numbers: 2023051188 2023060142 2023060144 2023060431 20…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 202 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2480-2025%22
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