Merlin™ 3650 Patient Care System Recall
Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.
Abbott is issuing a software update for the Merlin™ PCS 3650 programmer to address a potential issue during Pacing Capture Threshold testing of AVEIR Leadless Pacemakers.
What this Health Canada recall tells you, and what most readers miss
This notice was issued by Health Canada on May 27, 2026 and geographically references Canada. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Product & Food Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly Health Canada detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized Health Canada recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, health-canada, MedicalDevice) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
What Happened
Abbott is reaching out to customers regarding a Merlin™ PCS 3650 programmer software update. The update 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 the 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 performed during implant or clinic follow-up. It was identified through a review of complaints data, which confirmed four (4) complaints associated with the issue globally.
Which Products Are Affected
- Merlin Patient Care System - Programmer, model 3650
- Merlin PCS 3330 Software Upgrade Kit, model 3330 V28.1.4
- Merlin PCS 3330 Software Upgrade Kit, model 3330 VER 25.2.4
- Merlin PCS 3330 Software Upgrade Kit, model 3330 V25.8.4
- Merlin PCS 3330 Software Upgrade Kit, model 3330 V26.0.4
- Merlin PCS 3330 Software Upgrade Kit, model 3330 V27.0.4
- Merlin PCS 3330 Software Upgrade Kit, model 3330 V28.8.4
- Merlin PCS 3330 Software Upgrade Kit, model 3330 V25.4.4
- Merlin PCS 3330 Software Upgrade Kit, model 3330 V28.3.4
- Merlin PCS 3330 Software Upgrade Kit, model 3330 V28.2.4
The recalling firm is St. Jude Medical, Cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar, California, United States, 91342.
What You Should Do
Abbott is reaching out to customers to inform them about the software update. No further consumer action details are provided in the recall notice.
Why This Matters
The issue may result in sub-threshold pacing of an AVEIR Leadless Pacemaker if it occurs during testing.
Source
Original source: Health Canada Official Notice ↗
Related Product & Food Recalls
All Product & Food Recalls →Frequently Asked Questions
Common questions about this Health Canada recall.