Class 1 Recall of Medtronic SC Catheters and Revision Kit Models

The Food and Drug Administration (FDA) has issued a notification to healthcare professionals of the Class 1 recall of Medtronic SC Catheters and Revision Kit Models: 8709SC, 8731SC, 8578, and 8596SC when paired with the Medtronic IsoMed Pump Model 8472, due to a design incompatibility resulting in 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.

SC catheters are not compatible with IsoMed pumps but are compatible with Medtronic SynchroMed II and SynchroMed EL pumps. To date, Medtronic has received ten reports worldwide related to improper connection of an SC catheter to an IsoMed.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

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Published on Sep-25-09