Device recall
Z-0727-2008: Medtronic Cardioblate Gemini-s, model 49260. Surgical Ablation Device…
FDA device recall · Class II · Medtronic Cardiac Surgery Technologies
Key facts
| Recall number (Z-number) | Z-0727-2008 |
|---|---|
| Recall event | 45940 |
| Product | Medtronic Cardioblate Gemini-s, model 49260. Surgical Ablation Device. Sterilized using Ethylene Oxide. Two, unique jaw curvatures are provided: a standard curve (model 49260) and extra curve (Model 49261). The device is intended for intermittent operation. Manufacturer: Medtronic, Inc. Minneapolis… |
| Product code | GEI |
| Recalling firm | Medtronic Cardiac Surgery Technologies |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2011 |
| 510(k) numbers | K0700311 |
| FEI number | 3003368396 |
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