FDA Device recall Z-0984-2025
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
- FDA Device
- Class II
- ongoing
- Published 2025-01-29
On 2025-01-29 the FDA classified a Class II recall of DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr) by Medtronic Perfusion Systems, citing incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0984-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-12 |
| Published | 2025-01-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | US |
Product
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Reason
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Identifiers
| code_info | Model 77008 UDI-DI: 20763000091105, Lot Numbers: 2024010723, 202404C049; Model 77014 UDI-DI: 20763000091136, Lot Number: 2023121097 |
|---|
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-0984-2025%22
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