Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20927 |
| Brand Name: | Medtronic Amplia CRT-D Sure Scan |
| Model: | DTM2D1 |
| 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: | Medtronic Amplia CRT-D Surescan |
| Model: | DTMB2D4 |
| 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: | Medtronic Amplia MRI Quad CRT-D SureScan |
| Model: | DTMB2QQ |
| 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: | Medtronic Claria MRI CRT-D SureScan |
| Model: | DTMA2D1 |
| 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: | Medtronic Claria MRI CRT-D SureScan |
| Model: | DTMA2D4 |
| 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: | Medtronic Claria MRI QUAD CRT-D SureScan |
| Model: | DTMA2Q1 |
| 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: | Medtronic Claria MRI Quad CRT-D sureScan |
| Model: | DTMA2QQ |
| 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: | Phase 1: Manufacturer has identified a device software issue that may occur with all models of Claria MRI CRT-D SureScan and Amplia MRI CRT-D SureScan devices. The issue is a loss of LV pacing that occurs following a specific device programming sequence. As of November 10 , 2016, the manufacturer has observed an overall occurrence rate of 0.38%. But all tachyarrhythmia detection and therapy features remain fully operational. The software issue can be corrected by re-programming the device. The manufacturerwill also address an unrelated transient mode switch behaviour that may occur in MRI Quadripolar CRT-D device models (Claria MRI™, Amplia MRI™ and Compia MRI™). Phase 2: A software update is being developed to address this issue and will be communicated to clinicians once it becomes available The updated software (SW034 Software Version 8.2) is now available to correct the Issue 1 in the affected Claria MRI and Amplia MRI CRT-D SureScan devices. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/12/2016 |
