Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27546 |
| Brand Name: | Medtronic model 2090 programmer |
| Model: | IPGs: Azure™ XT DR MRI SureScan™, Azure™ S DR MRI SureScan™, Azure™ XT SR MRI SureScan™, Azure™ S SR MRI SureScan™ |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Inc |
| Brand Name: | CRDM - Carelink Encore Programmer Model 29901 |
| Model: | IPGs: Azure™ XT DR MRI SureScan™, Azure™ S DR MRI SureScan™, Azure™ XT SR MRI SureScan™, Azure™ S SR MRI SureScan™ |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Inc |
| Brand Name: | CRDM - CareLink Network Device Data Management Application |
| Model: | CRT-Ps: Percepta™ CRT-P MRI SureScan™, Percepta™ Quad CRT-P MRI SureScan™, Serena™ CRT-P MRI SureScan™, Serena™ Quad CRT-P MRI SureScan™ |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Inc |
| Brand Name: | CRHF - CareLink SmartSync Device Manager System |
| Model: | CRT-Ps: Percepta™ CRT-P MRI SureScan™, Percepta™ Quad CRT-P MRI SureScan™, Serena™ CRT-P MRI SureScan™, Serena™ Quad CRT-P MRI SureScan™ |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Inc |
| Issue: | The impedance measurement that is used should be based on the device's programmed polarity. However, for Orion and CRT-P Quad family of devices, the algorithm is coded to use the bipolar lead impedance measurement for the atrial and right ventricle leads, regardless of programmed polarity. This can result in the wrong impedance (and potentially an open-circuit impedance) being used to estimate longevity. This issue causes over-estimation of longevity in the first half of the battery's lifecycle. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 6/4/2021 |
