Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22363 |
| Brand Name: | VALITUDE X4 CRT-P U128 |
| Model: | |
| Affected: | Model U128 |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Cardiac Pacemakers Inc |
| Brand Name: | VISIONIST CRT-P U225 |
| Model: | |
| Affected: | Models U225, U226, U228 |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Cardiac Pacemakers Inc |
| Brand Name: | ACCOLADE MRI SR Pacemaker L310 |
| Model: | |
| Affected: | Models L310, L311, L331 |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Cardiac Pacemakers Inc |
| Brand Name: | PROPONENT MRI SR Pacemaker L210 |
| Model: | |
| Affected: | Models L210, L211, L231 |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Cardiac Pacemakers Inc |
| Issue: | The manufacturer has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturer's pacing lead system, but the manufacturer has determined it to be more likely for affected pacemakers using Medtronic or Abbott/St. Jude (Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV). |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 15/12/2017 |
