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Cardiomems patient electronics system

Official notice

18 Oct 2024

MediumHealth Canada

An official Health Canada notice concerns Cardiomems patient electronics system. Abbott has received reports of an issue following migration of the merlin.net patient care network hf portal to the cloud environment on September 30, 2024. Since then, certain patients have been impacted, and their patient electronics system may be sending incorrect pressure readings. While the issue is being investigated, Abbott is advising users to pause using these patients' pulmonary artery pressure readings for clinical decision-making or patient management. Recall start date: October 9, 2024 Published 2024-10-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76358

Official notice

2024-10-18

The hazard

Abbott has received reports of an issue following migration of the merlin.net patient care network hf portal to the cloud environment on September 30, 2024. Since then, certain patients have been impacted, and their patient electronics system may be sending incorrect pressure readings. While the issue is being investigated, Abbott is advising users to pause using these patients' pulmonary artery pressure readings for clinical decision-making or patient management. Recall start date: October 9, 2024

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

76358

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Affected products

Product 1

Affected products - CardioMEMS Patient Electronics System, Lot or serial number - S/N: V7LSK5, Model or catalogue number - CM1100

Risk / hazard

Abbott has received reports of an issue following migration of the merlin.net patient care network hf portal to the cloud environment on September 30, 2024. Since then, certain patients have been impacted, and their patient electronics system may be sending incorrect pressure readings. While the issue is being investigated, Abbott is advising users to pause using these patients' pulmonary artery pressure readings for clinical decision-making or patient management. Recall start date: October 9, 2024

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Abbott Medical, Cardiomems Patient Electronics System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

76358

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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