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Excor system cannulas

Official notice

17 Aug 2023

Last checked

17 Aug 2023

Critical riskHealth Canada

An official Health Canada notice concerns Excor system cannulas. The purpose of the urgent medical device correction notification is to advise healthcare professionals that Berlin Heart is conducting a voluntary correction concerning all Excor cannulae due to the potential of partial or complete breaches of an Excor cannula. A significant cannula breach may result in massive blood loss and/or an air embolism which could result in blood loss and/or death to the patient. No product will be removed. Recall Start Date: August 4, 2023 Published 2023-08-17.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74133

Official notice

2023-08-17

The hazard

The purpose of the urgent medical device correction notification is to advise healthcare professionals that Berlin Heart is conducting a voluntary correction concerning all Excor cannulae due to the potential of partial or complete breaches of an Excor cannula. A significant cannula breach may result in massive blood loss and/or an air embolism which could result in blood loss and/or death to the patient. No product will be removed. Recall Start Date: August 4, 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

74133

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Affected products

Product 1

Affected products - Excor System - Apex Cannulas, Lot or serial number - All lots., Model or catalog number - C14A-040M C18A-020 C22A-004 C27A-001

Product 2

Affected products - Excor System - Atrial Cannulas, Lot or serial number - All lots., Model or catalog number - C15V-040M C23V-004 C25V-004 C22V-002M C19V-020M C22V-004

Product 3

Affected products - Excor System - Arterial Cannulas, Lot or serial number - All lots., Model or catalog number - C60G-002M C85G-004 C80G-040M C85G-002M C60G-004M C80G-021M

Product 4

Affected products - Excor System - Connecting Set For Cannulas, Lot or serial number - All lots., Model or catalog number - A06-009 A09-012

Risk / hazard

The purpose of the urgent medical device correction notification is to advise healthcare professionals that Berlin Heart is conducting a voluntary correction concerning all Excor cannulae due to the potential of partial or complete breaches of an Excor cannula. A significant cannula breach may result in massive blood loss and/or an air embolism which could result in blood loss and/or death to the patient. No product will be removed. Recall Start Date: August 4, 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: Berlin Heart, Excor System Cannulas.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

critical

Recall details

Recall number

74133

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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