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Merlin™ 3650 patient care system (pcs)

Official notice

22 May 2026

Last checked

22 May 2026

Medium riskHealth Canada
Watch St Jude Medical Cardiac Rhythm Management Division

An official Health Canada notice concerns Merlin™ 3650 patient care system (pcs). 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. Published 2026-05-22.

What to do now

Contact the manufacturer if you require additional information.

Recall number

82105

Official notice

2026-05-22

The hazard

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.

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Skus

3650

Other

RA RA-82105

Model Numbers

3650

Recall Numbers

82105

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Affected products

Product 1

Lot or serial number - Not applicable., Model or catalogue number - 3650

Product 2

Lot or serial number - Not applicable., Model or catalogue number - 3330 V28.1.4

Product 3

Lot or serial number - Not applicable., Model or catalogue number - 3330 VER 25.2.4

Product 4

Lot or serial number - Not applicable., Model or catalogue number - 3330 V25.8.4

Product 5

Lot or serial number - Not applicable., Model or catalogue number - 3330 V26.0.4

Product 6

Lot or serial number - Not applicable., Model or catalogue number - 3330 V27.0.4

Product 7

Lot or serial number - Not applicable., Model or catalogue number - 3330 V28.8.4

Product 8

Lot or serial number - Not applicable., Model or catalogue number - 3330 V25.4.4

Product 9

Lot or serial number - Not applicable., Model or catalogue number - 3330 V28.3.4

Product 10

Lot or serial number - Not applicable., Model or catalogue number - 3330 V28.2.4

Product 11

Lot or serial number - Not applicable., Model or catalogue number - 3330 VER 25.0.4

Product 12

Lot or serial number - Not applicable., Model or catalogue number - 3330 VER 25.3.4

Product 13

Lot or serial number - Not applicable., Model or catalogue number - 3330 V28.0.4

Product 14

Lot or serial number - Not applicable., Model or catalogue number - 3330 V28.5.4

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

St Jude Medical Cardiac Rhythm Management Division

Manufacturer

Not provided

Phone

Not provided

Brand: St Jude Medical Cardiac Rhythm Management Division.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

82105

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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