Merlin Patient Care System Model 3650

Merlin Patient Care System Model 3650 Recall St Jude Medical is recalling the Merlin Patient Care System Model 3650 due to a software issue that requires an upgrade. This Class I recall affects hospitals, pharmacies, and laboratories in New Zealand that use this system. The recall was issued because the software needs to be updated to address the identified problem.

Recalling firm

Abbott Medical New Zealand Limited

Product

Merlin Patient Care System Model 3650. [Device]. Model: MERLIN 3650 PATIENT CARE SYSTEM (PCS). Affected: SOFTWARE MODEL 3330 V25.0.X – V28.7.X WHEN USED WITH AVEIR LEADLESS SYSTEM

Reason

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...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-05-11

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/2895b3d5-42ca-4bcb-b999-eed0156df554