Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36795 |
| Brand Name: | Merlin Patient Care System Model 3650 |
| Model: | MERLIN 3650 PATIENT CARE SYSTEM (PCS) |
| Affected: | SOFTWARE MODEL 3330 V25.0.X – V28.7.X WHEN USED WITH AVEIR LEADLESS SYSTEM |
| Software version: | |
| Recalling Organisation: | Abbott Medical New Zealand Limited 4 Pacific Rise Mt Wellingtion Auckland 1640 |
| Contact Information: | 0800 756 269 |
| Manufacturer: | St Jude Medical (USA) |
| Issue: | The manufacturer is contacting customers to inform them of a Merlin PCS 3650 programmer software update that addresses a potential software behaviour observed during the Pacing Capture Threshold (PCT) test of the AVEIR™ Leadless Pacemaker (LP). In rare circumstances, if intermittent loss of telemetry occurs during a PCT test, the programmer may not successfully transmit the command to terminate the test, which could result in the LP remaining in sub-threshold pacing until telemetry is fully disconnected. This issue can only occur during a PCT test, which is performed at the time of implant or during in-clinic follow-up. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 11/5/2026 |
