Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22361 |
| 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: | NG4 - RESONATE X4 CRT-D G447 |
| Model: | |
| Affected: | Model G447 |
| 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: | NG4 - MOMENTUM CRT-D G124 |
| Model: | |
| Affected: | Model G124, G125, G126, G128 |
| 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: | AUTOGEN CRT-D Model G172 |
| Model: | |
| Affected: | Models G172, G173, G175, G177, G179 |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Boston Scientific Corporation |
| 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: | DYNAGEN CRT-D Model G151 |
| Model: | |
| Affected: | Models G151, G156, G158 |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Boston Scientific Corporation |
| Issue: | The manufacturer has included important programming information to prevent an unintended asynchronous biventricular (BiV) pacing behavior when tracking elevated atrial intrinsic rhythms in certain Cardiac Resynchronization Therapy (CRT) pacemakers (CRT-Ps) and defibrillators (CRT-Ds). Repeated detection of this unintended asynchronous BiV pacing behavior may result in the implanted device reverting to a permanent Safety Mode (Safety Core) status thus requiring early replacement. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 15/12/2017 |
