DLP Pediatric One-Piece Arterial Cannulae — Class II medical device recall Z-0984-2025
Ongoing recall by Medtronic Perfusion Systems, reported 2025-01-29, distributed nationwide. Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
| Recall number | Z-0984-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2024-12-12 |
| Classified | 2025-01-17 |
| Reported by FDA | 2025-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 745 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 20763000091105, 20763000091136 |
| Lot numbers | 2023121097, 2024010723, 202404C049 |
| Model numbers | 77008, 77014 |
Product
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Reason for recall
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
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-0984-2025. 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.