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Dlp antegrade aortic root cardioplegia cannulae

Official notice

13 Feb 2025

MediumHealth Canada

An official Health Canada notice concerns Dlp antegrade aortic root cardioplegia cannulae. During the manufacturing process, unexpected loose plastic material in the male luer used in the aortic root cannula was identified. The potential harms when identified prior to use is procedure delay while another cannula is located. If this is not identified prior to use, and the clinician uses the cannula, the potential harm is stroke (reversible and irreversible). Recall Start Date: February 5, 2025 Published 2025-02-13.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76947

Official notice

2025-02-13

The hazard

During the manufacturing process, unexpected loose plastic material in the male luer used in the aortic root cannula was identified. The potential harms when identified prior to use is procedure delay while another cannula is located. If this is not identified prior to use, and the clinician uses the cannula, the potential harm is stroke (reversible and irreversible). Recall Start Date: February 5, 2025

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

76947

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Affected products

Product 1

Affected products - DLP Antegrade Aortic Root Cardioplegia Cannulae, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 11012 11014 11014L 21014 11012L 21012

Risk / hazard

During the manufacturing process, unexpected loose plastic material in the male luer used in the aortic root cannula was identified. The potential harms when identified prior to use is procedure delay while another cannula is located. If this is not identified prior to use, and the clinician uses the cannula, the potential harm is stroke (reversible and irreversible). Recall Start Date: February 5, 2025

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: Medtronic, Dlp Antegrade Aortic Root Cardioplegia Cannulae.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

76947

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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