FDA issues class I recall of certain Medtronic insulin pumps

Type 1 and LADA
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WRITTEN BY: Jordan Dakin

The FDA announced today that it has issued a recall of Medtronic MiniMed 600 Series insulin pumps as a result of problems reported with incorrect insulin dosing. This recall has been classified as a Class I recall, which is the most serious type of recall that can be issued. Use of Class I recalled devices can result in grievous injury or death.

Affected pumps are being recalled because of a missing or broken retainer ring, which works to keep the insulin cartridge in place within the pump reservoir. If that cartridge is not properly secured, insulin can be under- or over-delivered, resulting in hypo- or hyperglycemia.

According to the FDA, Medtronic has received a total of 26,421 complaints over this specific issue with the device, and the defect has resulted in 2,175 injuries and 1 death that the company knows of.

This news follows Medtronic issuing an “Urgent Field Safety Notification” for MiniMed 630G and 670G pumps in November of 2019, stating at the time that there had been reported incidents of the pump reservoir becoming loose when the retainer ring is broken or missing.

Pamela Reese, Medtronic’s Director of Global Communications, said “This recent classification of the recall does not introduce any new issues or generate new instructions for customers to return product that is working properly.”

Affected models include the MiniMed 630G (Model # MMT-1715, distributed September 2016 to October 2019) and the MiniMed 670G (Model # MMT-1780, distributed June 2017 to August 2019).

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The above photo from Medtronic shows the location of the retainer ring and what it should look like. The FDA advises customers who utilize a Medtronic MiniMed 600 Series pump to do the following:

  • Examine the retainer ring of the pump.
  • Stop using the pump and contact Medtronic for a replacement if the reservoir does not lock in properly or the retainer ring is loose, damaged, or missing. Perform manual insulin injections and follow your healthcare provider’s instructions if you stop using your pump.
  • Continue using your Medtronic pump if the reservoir correctly locks into place.
  • If the pump is accidentally dropped or bumped, check to ensure that the retainer ring is not damaged.
  • Check to make sure the retainer ring is not broken, damaged or missing and that the reservoir is properly secured during every set change.

Reese also said that, “Medtronic will replace pumps that have damage to the retainer ring and advises customers to examine their pump retainer ring during each infusion set and reservoir change to ensure the reservoir locks in place.”

Customers who have questions or need additional information or support about this recall should call the 24-hour Medtronic Technical Support at 877-585-0166.

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Dunno why this is making the rounds AGAIN. We heard about issues with the ring months ago.

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Yeah, I thought the same thing when I read the new flash. I don’t know if the death occurred after the first report or after and that is why the new push from a reporting standpoint.
But it seems like a quick check and frequent checks should keep people in a safe place.

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The ring is right on top. It’s kind of hard to not notice if it is damaged.

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Right, it seems to be something you would notice every time you do a site change. So I wonder how this is slipping by people. I would see that a make a quick call to Medtronic. It has been awhile since I worked with Medtronic but back in the day, they had great customer service!

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The retainer ring on my 523 broke about 1 year ago. When I called they told me not to use any more and they would send me a replacement in 3 days.

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Mine broke also on my 523. That is when I asked for a new pump. I used duct tape to hold my reservoir in (just to keep it from rotating out), until I got a loaner.

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I still get fda recall notifications for my 723/530g pumps. The oblong oval piece on the bottom of the pump was the issue, I believe. Haven’t used them in years, the recall for the 600 series was started voluntarily by Medtronic over a year ago. Guess letting them self regulate didn’t work out so well.

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I thought this recall was limited to the 600 series pumps. I just checked my spare 722 and see that it also has this retainer ring. I wonder if the recall is limited to more recently manufactured pumps that are still under warranty.

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It appears that my retainer ring is damaged but upon closer inspection with magnifying optics and good light show it is still sound.

This retaining ring is part of Med-T’s custom design that makes their infusion sets proprietary.

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This is the same recall as was noticed last November. All people with pumps were noticed last year if the pumps were involved. It is a very narrow range of manufacture. However, if you have any question call the 800 number and they will verify if your pump is involved. Likewise if the ring on your pumps breaks, stop using it and call the 800 number for a replacement.

rick

Note: I am a Medtronic ambassador. My opinions are my own. They did not pay me to say nice things. OK, they sent me a shirt and a cup but even I am more expensive than that.

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Years…hasnt this been around for years now???

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Isn’t it irritating when old news is camouflaged as breathless new news?

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Since last November, the FDA rereleased the information yesterday.

Note: I am a Medtronic ambassador. My opinions are my own. They did not pay me to say nice things. OK, they sent me a shirt and a cup but even I am more expensive than that.

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I was an Animas and Medtronic 723 user. Wasn’t there always a recall about the cartridge caps and leaks and pressure and etc. etc etc.?

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I think so.

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As I recall in the 723 days, Medtronic had a recall on pump reservoirs. I also seem to recall a broken body issue. This is different however.

Note: I am a Medtronic ambassador. My opinions are my own. They did not pay me to say nice things. OK, they sent me a shirt and a cup but even I am more expensive than that.

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Bottom of the pump where the battery end cap was seated is a recall I still get notified about yearly.

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I heard about it awhile ago. I think the re ssue is someone who used one of the 6 series pumps passed away and the retainer ring on their pump might have been a factor of poor control possibly leading to their untimely demise. This is just speculation on my part. Like all of the pharma ads we see on TV, if someone was in the test group and was killed in a car accident, they have to legally list “death” as a possible side effect.

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Just to continue to point out. the recall applies to the clear plastic ring versions. If your pump does not include a clear plastic ring it is not being recalled. it is a very, very narrow recall.

Note: I am a Medtronic ambassador. My opinions are my own. They did not pay me to say nice things. OK, they sent me a shirt and a cup but even I am more expensive than that.

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From what I understand, the “reissue” more comes from how the FDA does recalls and reporting. As I understand it, Medtronic reported the problem to the FDA in November and notified patients affected. Then they have to do some sort of report or data gathering, the number of people affected, the number of complaints, the problems that occurred- that type of thing- then they submit that to the FDA and from there the FDA makes a decision based on the information received.