Device recall event
Recall event 78888: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA device recall · Class I · Terminated
Key facts
| Recall event number | 78888 |
|---|---|
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Recall class | Class I |
| Status | Terminated |
| PMA numbers | P010031, P010031S318, P010031S442, P010031S513, P010031S550, P980016, P980016S382, P980016S536, P980016S551, P980016S586 |
At a glance
- 1–9 Recalled products (Z-numbers)
- None Linked 510(k)s
- 10–99 Recall events for this firm
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recall events
A recall event groups every recalled product (Z-number) from one recall action by a firm. Class I recalls involve a reasonable probability of serious harm; Class III recalls are unlikely to cause harm.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database