DLP Left Heart Vent Catheter Malleable body and vented connector — Class I medical device recall Z-2480-2025
Ongoing recall by Medtronic Perfusion Systems, reported 2025-09-10, distributed nationwide. The catheters may not retain their shape.
| Recall number | Z-2480-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2025-08-06 |
| Classified | 2025-09-03 |
| Reported by FDA | 2025-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 34,549 units |
| UPC / GTIN / UDI-DI | 00643169881334, 00673978176475, 20643169881338 |
| Serial numbers | 2023051188, 2023060142, 2023060144, 2023060431, 2023060762, 2023061146, 2023070147, 2023070148, 2023070149, 2023070150, 2023070151, 2023070490, 2023070979, 202307C112, 2023080156, 2023080797, 2023080798, 2023081130, 2023081131, 2023081132, 2023081547, 2023081548, 202308C248, 202308C249, 2023090234 and 56 more |
| Model numbers | 12113 |
Product
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
Reason for recall
The catheters may not retain their shape.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2480-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.