Medtronic Infusion Device Recall: No Reason to Panic

Last month, Medtronic announced a voluntary recall/replacement for many of their popular Paradigm infusion devices, including the Mio, Quick Set, and Silhouette.

Interestingly, the problem is not with the tubing or the infusion set itself… it is with the connector that attaches the tubing to the insulin reservoir.  This piece, called a “P-Cap”, contains a vent that allows pressure within the reservoir to remain consistent with outside air pressure.  If this vent become clogged, pressure within the reservoir can exceed outside air pressure, and can result in unintended movement of insulin out of the reservoir, through the tubing and infusion set, and into the user’s body.  And we all know where that can lead.

The potential for vent clogging has existed since Paradigm-compatible infusion devices were first developed.  The problem came to a head with the advent of the 630G and 670G pumps, which are deemed water-tight by the manufacturer.  With more people wearing their pumps in the water, the potential for clogging has increased – but only if the P-Cap is not attached properly to the reservoir.  When attached properly, the vent’s membrane is sealed from exposure to moisture, so clogs don’t take place.  If the P-Cap is attached improperly (i.e. at a “bent angle” to the reservoir), insulin can leak out and block the vent, and water from pump submersion can also block the vent.

The incidence of reported problems related to the P-Cap has been very rare (1-2 per million infusion sets).  Nevertheless, Medtronic redesigned the P-Cap to eliminate the problem and is offering to replace older infusion devices with new ones, free of charge.  Does this mean that you should not use the older infusion sets with the original P-Cap?  As long as you attach the P-Cap properly to the reservoir, the answer is no.  But if you want to play it extra safe, go ahead and contact Medtronic to order replacements.

I’d like to give Medtronic credit for stepping up.  Given the relatively small number of problems reported, they could have just kept their fingers crossed and hoped the complaint-line phone wouldn’t light up.  But they took a proactive approach.  Replacing infusion devices for hundreds of thousands of customers is not cheap!

To see if your infusion devices are part of the recall, visit https://checklots.medtronicdiabetes.com.  Outside the US, visit www.mmc.medtronic-diabetes.com/look.

If you have any questions, comments or concerns, please call Medtronic’s customer service hotline:  +1-800-204-7616