Recall · FDA
Boston Scientific Corporation
Boston Scientific Corporation issued a Class II FDA recall (Z-3255-2018) initiated 2018-09-10: ESSENTIO Pacemaker
| Company | Boston Scientific Corporation |
|---|---|
| Recall number | Z-3255-2018 |
| Classification | Class II |
| Status | Terminated |
| Category | Devices |
| Initiated | 2018-09-10 |
| Product | ESSENTIO Pacemaker |
| Reason | Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion. |
FAQ
What did Boston Scientific Corporation recall?
ESSENTIO Pacemaker
Why was Boston Scientific Corporation's product recalled?
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.