Recall MonitorHealth Products
Merlin™ 3650 Patient Care System (PCS)
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Merlin™ 3650 Patient Care System (PCS)
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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. | 3330 VER 25.0.4 |
| Merlin PCS 3330 Software Upgrade Kit | Not applicable. | 3330 VER 25.3.4 |
| Merlin PCS 3330 Software Upgrade Kit | Not applicable. | 3330 V28.0.4 |
| Merlin PCS 3330 Software Upgrade Kit | Not applicable. | 3330 V28.5.4 |
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.