Excor System Cannulas
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Excor System - Apex Cannulas |
All lots. |
C14A-040M |
Excor System - Atrial Cannulas |
All lots. |
C15V-040M |
Excor System - Arterial Cannulas |
All lots. |
C60G-002M |
Excor System - Connecting Set For Cannulas |
All lots. |
A06-009 |
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
Berlin Heart gmbh
Wiesenweg 10, Berlin, Germany, 12247
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