Back to RecallTracker
Health Canada Medical devices

Becker and Exacta External Drainage and Monitoring Systems

Issued November 14, 2024
Issue
Medtronic has received customer complaints reporting cracks and/or leaks on the stopcock of Becker and Exacta EDMS devices. On these devices, the stopcocks may be in three different locations in the EDMS, depending on the specific system configuration. Cracks or leaks of the stopcock can compromise line integrity and, as a result, present a potential for infection. Three adverse events associated with patient infection have been reported. Recall start date: November 1, 2024
Hazard description
Performance
Product
Product name
Becker and Exacta External Drainage and Monitoring Systems
Reference
ID
RA-76501