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Cardiomems hospital electronics system

Official notice

23 Feb 2023

MediumHealth Canada

An official Health Canada notice concerns Cardiomems hospital electronics system. The Cardiomems HF System is intended to operate at frequencies between 30 and 37.5 MHz. Abbott has found that a small number (less than 1%) of implanted Cardiomems PA sensors (model CM2000) have operated outside of this intended radiofrequency range at least once over the life of the implant when interrogated by Cardiomems patient or hospital systems (models CM1100 and CM3000). Operating frequency may be affected by atmospheric conditions, elevation, pulmonary artery (pa) pressure, and unique sensor and patient characteristics. Recall start date: February 7, 2023 Published 2023-02-23.

What to do now

Contact the manufacturer if you require additional information.

Recall number

72929

Official notice

2023-02-23

The hazard

The Cardiomems HF System is intended to operate at frequencies between 30 and 37.5 MHz. Abbott has found that a small number (less than 1%) of implanted Cardiomems PA sensors (model CM2000) have operated outside of this intended radiofrequency range at least once over the life of the implant when interrogated by Cardiomems patient or hospital systems (models CM1100 and CM3000). Operating frequency may be affected by atmospheric conditions, elevation, pulmonary artery (pa) pressure, and unique sensor and patient characteristics. Recall start date: February 7, 2023

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

72929

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Affected products

Product 1

Affected products - Cardiomems Hospital Electronics System, Lot or serial number - All lots., Model or catalog number - CM2000

Product 2

Affected products - Cardiomems Hospital Electronics System, Lot or serial number - All lots., Model or catalog number - CM3000

Risk / hazard

The Cardiomems HF System is intended to operate at frequencies between 30 and 37.5 MHz. Abbott has found that a small number (less than 1%) of implanted Cardiomems PA sensors (model CM2000) have operated outside of this intended radiofrequency range at least once over the life of the implant when interrogated by Cardiomems patient or hospital systems (models CM1100 and CM3000). Operating frequency may be affected by atmospheric conditions, elevation, pulmonary artery (pa) pressure, and unique sensor and patient characteristics. Recall start date: February 7, 2023

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 Hospital Electronics System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

72929

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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