Device recall
Z-0582-2018: Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled…
FDA device recall · Class I · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Key facts
| Recall number (Z-number) | Z-0582-2018 |
|---|---|
| Recall event | 78888 |
| Product | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: d. Amplia MRI CRT-D DF1 (Product No… |
| Product code | NIK |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 27, 2021 |
| 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