Recall · FDA
Boston Scientific Corporation
Boston Scientific Corporation issued a Class II FDA recall (Z-0373-2018) initiated 2017-12-07: PROPONENT SR Pacemaker
| Company | Boston Scientific Corporation |
|---|---|
| Recall number | Z-0373-2018 |
| Classification | Class II |
| Status | Ongoing |
| Category | Devices |
| Initiated | 2017-12-07 |
| Product | PROPONENT SR Pacemaker |
| Reason | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). |
FAQ
What did Boston Scientific Corporation recall?
PROPONENT SR Pacemaker
Why was Boston Scientific Corporation's product recalled?
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).