FDA Device recall Z-1306-2025
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, mode…
- FDA Device
- Class I
- ongoing
- Published 2025-03-19
On 2025-03-19 the FDA classified a Class I recall of Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, mode… by Medtronic Perfusion Systems, citing unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if n….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1306-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-02-05 |
| Published | 2025-03-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | US |
Product
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014
Reason
Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).
Identifiers
| code_info | 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 i. UDI-DI 00613994495457, lots 2022050698…1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 i. UDI-DI 00613994495457, lots 2022050698 2022070054 2023040161 2024040471 2024040475 2024051027 2024051028 ii. UDI-DI 00673978175959, lots 2022050698 2022060347 2022061333 2022081070 2023020720 2023030372 2023031531 2023100234 2023100235 2023120484 2024030256 2024040475 iii. UDI-DI 20613994495451, lots 2022020438 2022030157 2022030297 2022030478 2022030747 2022040309 2022040902 2022050053 2022050697 2022050698 2022060347 2022061333 2022070054 2022070055 2022081070 2022081428 202209C071 202211C054 2023020719 2023020720 2023030372 2023031531 2023040161 2023040433 2023040806 2023041172 2023050066 202305C067 202307C101 2023100087 2023100234 2023100235 2023100489 2023100490 2023100876 2023111145 2023111146 2023120073 2023120484 2023120485 202312C018 2024011341 2024011342 2024011344 202401C303 202401C304 2024020238 202402C163 2024030255 2024030256 2024030692 2024040471 2024040472 2024040473 2024040474 2024040475 |
|---|
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-1306-2025%22
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