Medical Device Recall: Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP¿ Left Heart Vent Catheter 13 Fr., M
Medtronic Perfusion Systems · March 19, 2024
Reason for Recall
Potential for unsealed sterile packing.
Product Description
Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001, d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113, e) DLP¿ Left Heart Vent Catheter 16 Fr., Model Number 12016, f) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12002, g) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12220, h) DLP¿ Pericardial Sump 38.1 cm (15 in), Model Number 12010,
Distribution
Worldwide distribution.
Quantity Affected
13954 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1797-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.