Are they or aren't they?

Apparently Medtronic has announced to the public (or at least, it’s just made the news) that they are recalling the 630 & 670 pumps sold before October/August, 2019.

Yet when I read the notice, it appears they’re not actually “recalling” them, but warning us about a possible problem with the reservoir ring, and we should contact them if it “seems loose.” WTF??? A recall, or not a recall?

For the first time in 18 years of pumping, last week I had what I thought were two bad sites…bg’s went up to 400’s (luckily I don’t produce ketones)…finally gave myself a shot, which worked, so I changed the site…which failed within a day. It’s working fine now, but…

I’ve never had scar tissue that I’ve noticed, so I’m wondering if, despite looking fine, I should contact them and ask for a replacement?

What do you all thing?

My 670 is fine. If the ring were broken, I’d call for a replacement. Simple. No thought required.

I get that Dave, but then…why are they calling it a recall? It’s more like “if it’s broke, call us.” That’s not what I would consider a recall, but maybe I’m just being a language nitpicker!

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In my doubtful self of any large company, to me it means they know there is an issue but don’t want the liability of an actual recall and replacing everyone’s pump.

It’s kind of like the car companies when they know there is an issue and they say if you have a problem with this part before 100,000 miles we will replace it free.

To me that means they know it is breaking for people, but not everyone is having the problem so they don’t want to replace everyone’s.

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I agree, it is so easy for a user to see if their pump is damaged, and they don’t need an official notice of any type from Medtronic, to have the presence of mind to get on the phone with tech support and report the issue in order to receive a replacement. “Recall” to me means that one returns a product for inspection/possible replacement or repair. The whole thing smacks of ignorance of English, IMO. They could have done a better job of communication, IMO.

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There were over 26,000 customer calls about broken retainer rings and it was on pumps manufactured in a specific time frame. This points to a manufacturng error probably due to substandard materials. It seems unlikely that over 26,000 users happened to drop their pumps just right to break the “perfectly-to-spec” retaining ring. It seems to me that all of the pumps in the suspected time range are a problem waiting to happen and will require constant vigilance by users. It is just a matter of time before one breaks, the user fails to notice and ends up in severe trouble or worse, it causes another death. I think Medtronic is too motivated by profit rather than the well being of their customers. That’s why I am no longer a Medtronic customer. All of the suspect pumps should be recalled and replaced.

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Do you realize that Medtronic has replaced countless pumps for all sorts of user-caused damage or complaints? I’ve had pumps replaced for a variety of reasons, but one of those reasons includes that I complained about some scratches on the screen. I doubt Medtronic is going to do it your way. :slight_smile:
Corporations have a fiduciary duty to their shareholders.

Similar to how Ford calculated how many deaths they could pay out for and not have to fix the Pinto death trap?

Shall we talk about how many deaths there are from distracted driving? Or caused by drunk/impaired drivers? There are no guarantees in life, so stop expecting them.

OK, last response since now we are straying from corporate product liability to personal behavior responsibility. In one case the culpability lies with the corporation that sold you an unsafe product (not you for buying it), in the other it lies with whoever was distracted or drunk and caused the mayhem. There was no contract involved.

I’m not a Medtronic user so this doesn’t affect me and I haven’t looked into what exactly is going on… But the term “recall” has a much broader definition to the FDA than those of us on the user-end would expect. There are many stages of both voluntary and involuntary recalls.

Basically, there is no governing authority for the FDA. It is it’s own judge, juror, and executioner… And the executioner strikes first. When a complaint is lodged, a low level recall, and often a cease and desist letter, is issued (and generally ignored until the manufacturer gets to defend themselves). The manufacturer then gets to appeal the recall or try to remedy the issue. It’s then possible to elevate the recall to higher levels, and ultimately end-level involuntary status where the FDA demands the whereabouts of every single serial number produced and ensures that each and every single one has been collected and accounted for. That is a very last resort, though.

The reality is that most “recalls” you hear about in the media are just scare tactics of the competitors and/or media click-bait, and don’t actually equate to a serious concern and/or a physical collection of affected devices. It’s just FDA-speak for “a problem has been noted, what are you doing to fix it?”

However, to those saying that this is old news, I’m guessing either a higher level recall was issued or a new one had to be issued to include devices otherwise not included in the first recall.

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It could be that they passed some threshold for the number of complaints or incidence of injury. They call it a ‘class I’ recall. " The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death."

The terminology is a little confusing because a Class 1 medical device is less critical than a class 3 device. But, a class 1 warning is more critical than a class 3 warning.


Thanks to all of you for your input. Mohe…I didn’t know about the different classes of medical devices and, separately, the different classes of recalls. I’m guessing maybe Medtronic raised the class of the recall to a one, which is why it made the news again (and why I got several calls from friends wanting to make sure I knew about it.)

Me either. I suspect that fewer than 1 person out of 100 knows about different classes of recalls. Nor do I think we need to know. When I read a recall i don’t need the legal jargon–they just need to tell me what is a possible fault and how I can check for it and if they are going to replace my unit BEFORE I send it back. :slight_smile: