Device recall
Z-1306-2025: Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD…
FDA device recall · Class I · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-1306-2025 |
|---|---|
| Recall event | 96259 |
| 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… |
| Product code | DWF |
| Recalling firm | Medtronic Perfusion Systems |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K100274 |
| FEI number | 1000116158 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database