Device recall
Z-0962-2017: Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT…
FDA device recall · Class II · Medtronic Inc., Cardiac Rhythm and Heart Failure
Key facts
| Recall number (Z-number) | Z-0962-2017 |
|---|---|
| Recall event | 75943 |
| Product | Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and… |
| Product code | NIK |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 16, 2019 |
| PMA numbers | P010031, P010031S513, P010031S550 |
| FEI number | 2182208 |
At a glance
- None 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