Kaleido Safety Notice

Kaleido (an insulin pump manufacturer in Europe) has issued a safety notice about their insulin cartridges. That’s probably not relevant to anyone here, but I was quite shocked to read how serious their issue is. I mean, I sometimes get some safety notice letter from Medtronic and usually toss it away, because the issue isn’t that serious or relevant. Below is a quote from Kaleido’s statement (emphasis mine). Have you ever seen something like this before?

Unfortunately, due to an issue with one of our key suppliers, there is a risk of the tubing detaching from our Kaleido insulin cartridge, which can lead to reduced or no insulin being delivered. We put the safety of our customers first and have deemed the risk too high. Therefore, our customers have to stop using our cartridges immediately and destroy the supply they still have.

As it is unclear how long it will take to re-supply our customers, we advise our active customers to seek another form of insulin therapy.

In their Dutch statement, they also say they’ve made an agreement with Medtronic and offer their customers to switch to the 640G or 670G if they like.

Here is the whole statement:


Well, they say:

there is a risk of the tubing detaching from our Kaleido insulin cartridge, which can lead to reduced or no insulin being delivered

But surely that applies to all tubed insulin pumps? It also applies, in a different way, to the non-tubed Omnipod. If the catheter gets pulled out the insulin just functions as skin cream. This is quite common; it’s happened to me once (with precisely the results Kaleido describe) and other people have reported similar issues. There is an occlusion detection mechanism in the Omnipod and, I assume, tubed pumps, but detecting the opposite; the tube/catheter floating in the air, is not something the manufacturers have bothered with yet.

Surely it is obvious if this happens? It was to me; my BG went through the roof.


Apparently the risk is much higher with the Kaleido pump. Why else would a company take such drastic measures? With most pumps, I actually don’t think it’s that easy to accidentally detach the tubing from the insulin reservoir. For example, you can’t detach the tubing from a Medtronic pump without first removing the reservoir from the pump. I don’t know how this works with a tubed patch pump like Kaleido though.

Yes, I think all pumps have an occlusion detection mechanism, but I guess it’s much harder to detect a ripped out cannula.

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It must be happening at quite a high rate for them to ask for all current stock to be destroyed.

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