Medtronic SC catheters recall – serious injury or death possible
September 25, 2009 by allenh
Filed under Defective Medial Devices
Certain Medtronic SC Catheters and Revision Kit Models may pose a risk of serious injury or death to patients when paired with the Medtronic IsoMed Pump Model 8472 according to the FDA.
Here is a list of models issued for the Class 1 recall by the FDA:
8709SC
8731SC
8578
8596SC
This is because of a design compatibility issue causing a physical interference between the SC catheter connector and the IsoMed pump.
This may prevent the SC catheter from completely connecting to the IsoMed pump, even though it may appear to be connected and feel secure and may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death.
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