Device recall
Z-0585-2018: Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the…
FDA device recall · Class I · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Key facts
| Recall number (Z-number) | Z-0585-2018 |
|---|---|
| Recall event | 78888 |
| Product | Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1 (Product No. DDMC3D1); EXPANSION: e… |
| Product code | LWS |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 27, 2021 |
| PMA numbers | P980016, P980016S536, P980016S586 |
| 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