Medtronic Perfusion Systems Recall: Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CAN
Medtronic Perfusion Systems Recall: Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CAN is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Medtronic Perfusion Systems; Product: Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA
| Recalling firm | Medtronic Perfusion Systems |
|---|---|
| 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 for recall | 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). |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Ongoing |
| Distribution | Domestic distribution nationwide. International distribution to the following countries: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bosnia And Herzegovina Botswana Brazil Bulgaria Canada Canary Islands Cayman Islands Chile China Colombia Costa R |
| Recall initiated | 20250205 |
| Recall number | Z-1306-2025 |
| Category | device |
| State | MN |
| Country | United States |
$29/mo
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