Health Canada22 May 2026
Merlin™ 3650 Patient Care System (PCS)
Health Canada published a recall notice for Merlin™ 3650 Patient Care System (PCS) on 22 May 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 22 May 2026
- Recall type
- Health product recall
- Companies
- St. Jude Medical, Cardiac Rhythm Management Division · 15900 Valley View Court, Sylmar, California, United States, 91342
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
Issue: Abbott is reaching out to customers to inform about a Merlin™ PCS 3650 programmer software update that addresses a software behavior that may occur during Pacing Capture Threshold (PCT) test of an AVEIR™ Leadless Pacemaker (LP). If intermittent loss of telemetry occurs during PCT test, the programmer may not successfully communicate the command to terminate the test, potentially leaving the LP in sub-threshold pacing until telemetry is fully disconnected. This issue can only occur during a PCT test, which is performed during implant or in clinic follow-up. This issue was identified through a review of complaints data, which confirmed four (4) complaints associated with the issue globally. Additional information Details Original published date: 2026-05-22 Affected products: Affected products Lot or serial number Model or catalogue number Merlin Patient Care System - Programmer Not applicable. 3650 Merlin PCS 3330 Software Upgrade Kit Not applicable. 3330 V28.1.4 Merlin PCS 3330 Software Upgrade Kit Not applicable. 3330 VER 25.2.4 Merlin PCS 3330 Software Upgrade Kit Not applicable. 3330 V25.8.4 Merlin PCS 3330 Software Upgrade Kit Not applicable. 3330 V26.0.4 Merlin PCS 3330 Software Upgrade Kit Not applicable. 3330 V27.0.4 Merlin PCS 3330 Software Upgrade Kit Not applicable. 3330 V28.8.4 Merlin PCS 3330 Software Upgrade Kit Not applicable. 3330 V25.4.4 Merlin PCS 3330 Software Upgrade Kit Not applicable. 3330 V28.3.4 Merlin PCS 3330 Software Upgrade Kit Not applicable. 3330 V28.2.4 Merlin PCS 3330 Software Upgrade Kit Not applicable.
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.