Excor System Cannulas
Brand(s)
Last updated
Summary
Product
Excor System Cannulas
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Excor System - Apex Cannulas | All lots. | C14A-040M C18A-020 C22A-004 C27A-001 |
| Excor System - Atrial Cannulas | All lots. | C15V-040M C23V-004 C25V-004 C22V-002M C19V-020M C22V-004 |
| Excor System - Arterial Cannulas | All lots. | C60G-002M C85G-004 C80G-040M C85G-002M C60G-004M C80G-021M |
| Excor System - Connecting Set For Cannulas | All lots. | A06-009 A09-012 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Berlin Heart gmbh
Wiesenweg 10, Berlin, Germany, 12247
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-74133
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