The ship is taking on water

As if Medtronic doesn’t have enough problems with their diabetes franchise now word is spreading of, yet another insulin pump recall this one impacting over 320,000 pumps. This recall which apparently began in November of last year is related to an issue with the pump’s retainer ring. Per a notice on the company’s web site;

“The MiniMed™ 600 series insulin pump is designed with a pump retainer ring to lock the reservoir in the insulin pump. There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. The retainer ring can be broken, for example, as a result of dropping or bumping your pump on a hard surface.”

The entire notification can be found at http://www.medtronicdiabetes.com/customer-support/product-and-service-updates/notice12-letter

This recall follows the recall related to cybersecurity risks also from November of last year. Strangely the recall related to the retainer ring is not found on the FDA’s web site. Perhaps that is why this issue is just being discovered today. Regardless this is just one more nail in the Medtronic Diabetes coffin.

Not only are they having major issues with their crappy sensor, dealing with the launch of the Control IQ from Tandem (which is eating the 670G for lunch) they now must replace defective units due to this retainer ring issue. This as Momma Kliff used to say is like throwing more water onto the Titanic after it has hit the iceberg.

Oh and we forgot to mention that according to several sources the company has received numerous complaints on this is issue and one death has been attributed to the issue. Therefore you can take it to the bank that yep they are about to face another lawsuit. Lawsuits are nothing new to Medtronic, but this doesn’t mean they are pleasant to deal with.

Now lots of people are going to make a big deal out of this and we understand why. Yet there is a much bigger issue more like a HUGE issue as this recall combined with the Control IQ launch is putting the entire diabetes franchise at risk, and NO this is not an overstatement. It’s already well known that when it comes to patients new to pump therapy Medtronic is NOT the first or even second choice. The only reason Medtronic picks up any new patients is directly tied to their dominance in the formulary, a dominance which is fading.

The key for Medtronic has been and continues to be protecting the goose that lays all those golden eggs, their installed user base. This base not only generates significant pump supply and CGM revenue but carries with it the additional benefit of upgrade revenue. As we noted numerous times should the company experience any serious erosion to their installed user base the golden goose is cooked.

Although it’s still early in the Control IQ launch early evidence suggest this could well be happening. Add in Insulet’s very successful move to the pharmacy channel combined with their pay as you go platform, and this move away from Medtronic to other systems could go from a small problem to an ENORMOUS problem. And let’s be very clear about this there is absolutely nothing in the Medtronic pipeline that’s close enough to launch that will help stem this move.

We knew Mr. Salmon would be swimming upstream when he took over, but little did he know that this swim would be against a tsunami. It’s not yet game, set, match but it’s getting damn close to that. The fat lady is warming up.