Minimed has just recalled *ALL* pumps

[rickst29]

But I'll *GUESS* it's only required to send back if you've worn it while getting an MRI. If so, when you call them, they'll ask if you're SURE that's it's never been exposed to an MRI: and if it's never been exposed, maybe they'll let you keep it.

PRODUCT:
Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722, Recall # Z-1007-2007
CODE:
All serial numbers for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722
RECALLING FIRM/MANUFACTURER:
Medtronic MiniMed, Northridge, CA, by letters on April 24, 2007. Firm initiated recall is ongoing.
REASON:
Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemia.
VOLUME OF PRODUCT IN COMMERCE:
334,000 pumps
DISTRIBUTION:
Nationwide and Internationally


Here's the FDA's enforcement listing where it was announced-- it's right near the bottom.
http://www.fda.gov/bbs/topics/enforce/2007/ENF01012.html

[Amy C.]

Wow, that is a huge recall. Minimed has a lot of pumps out there.

[Abby-Dabby-Doo]

I only understood this to be if you had the pump on while having an MRI done.


We received a letter from the company (MM).

[rickst29]

MRI will kill most ANYTHING electronic. But because the Minimed "mode of failure" is dangerous overdose, the FDA has ordered some kind of action to be done on every single one they've ever made. Way back to the 511, anyway, which was before Medtronic even bought them. As I posted, I'm guessing that they only need to confirm that you HAVEN'T had an MRI while wearing it.

You're saying they only send a letter, and you don't even CALL BACK to confirm that haven't exposed the pump?

[Abby-Dabby-Doo]

You're saying they only send a letter, and you don't even CALL BACK to confirm that haven't exposed the pump?


I guess I'm confused:confused:~ and I hope I'm misreading your TONE:mad:~ your asking me why I don't even CALL BACK to confirm that my daughters pump hasn't been exposed to an MRI.

It was a brand new pump, at least I assume it was when it comes out of a sealed box from the company. We've only had the pump for a little over 2 months and my daughter has never had an MRI. I also check my daughters pump, to make sure she hasn't CLEARED any alarms that I need to know about.

[Brensdad]

My guess is that Minimed probably sells a lot of refurbished pumps. When you upgrade through the Pathway Program then they tell you it's refurbished, so even though neither Emma or I have been in for an MRI, the previous owner might have. Interesting!

[jules12]

I just called minimed. It is a Type II Action which means they do not actually recall all the pumps. Type II means that the FDA rates it lower than other types of recalls. The Minimed guy said unless you have had an MRI recently, there was no need for concern. I would say if you have any doubts or are worried about a refurbished pump, to contact them.

[kiwikid]

This is the info we recieved

I have listed the recall notice under issued by the US FDA.
PLease note however, that it is really a safety advice. You should know
that if you wear a Pump they ARE NOT TO BE WORN DURING AN MRI SCAN. (They need to be removed). However in the US one person wore their Paradigm Medtronic Pump thru an MRI scan. After this the Pump began overdelivering Insulin. The FDA and Medtronic agreed to issue an advice about this ....
Only Pumps worn during an MRI scan are affected by this recall. For
everyone else THERE IS NOT A PROBLEM.

[sam1nat2]

I just called them, they are saying it is not a full recall. Only for pumps worn during MRI scan.

I asked specifically about refurbished pumps and was told that new pumps are never shipped as refurbished, only replacement ones.

As long as your kiddo hasn't worn the pump for a MRI, you are fine!!

[lilituc]

However in the US one person wore their Paradigm Medtronic Pump thru an MRI scan.

I don't even know what to say about this. I mean, they tell you for an MRI, NOTHING metal, no electronic devices. I don't even get how that happened. Wouldn't the staff notice?

[Mama Belle]

I don't even know what to say about this. I mean, they tell you for an MRI, NOTHING metal, no electronic devices. I don't even get how that happened. Wouldn't the staff notice?

My thoughts exactly! ;)

[sam1nat2]

no accounting for idiots out there. I remember a case here a few years ago where an o2 tank was in the room when MRI went off, flew across the room injuring the kid!!

[s0ccerfreak]

[QUOTE=sam1nat2;53933]
I asked specifically about refurbished pumps and was told that new pumps are never shipped as refurbished, only replacement ones.QUOTE]

So, if we had a pump break and they sent us another one, that one would've been a refurbished pump? We got the pump a year ago so I don't remember if it said anything about it being new or refurbished.
Where did you find this information about all the pumps being recalled?-We haven't received anything other than a letter saying not to where it while getting xrays or MRIs done.

[Heather(CA)]

Seth doesn't use a pump...But, I'm curious, what about the x-ray machines in airports???

[Kaylee's Mommy]

Seth doesn't use a pump...But, I'm curious, what about the x-ray machines in airports???


the pumps shouldn't go through the x-ray machines, but they are fine to go through the walk through metal detector.. DO NOT take it off your body to be x-rayed..

as for getting replacement pumps.. the pump you receive when you first buy it is brand new.. if you need a replacement (we've had 4) its refurbished.. it could mean that it was simply sent out and returned but if the box is opened it needs to go through a whole system check.. when we first replaced Kaylee's pump they said what they are really interested in is the case of the pump.. not the mechanics itself.. they redo everything, clean it up and send it back out.. all the pumps that we've had have looked brand new.. and if you are using a 522 or 722.. the pumps only came out last year, so its not like they are 5 years old and sending them out to you...

we received this letter as well,but I never called them.. I know Kaylee hasn't worn it in an MRI or any thing other than the metal detector at the airport.

[sam1nat2]

I called them and they did not say a thing about airport security. I would think they would make a bigger deal out of that since it is more common than a MRI.

As for refurbished, remember, they have to meet FDA requirements. I'm sure the pump gets tested in quality control before being sent out.

I heard a story about a pump company (which is no longer around) where the pumps were defective and the entire cartridge went off, giving the entire amount of insulin at once. Happened twice, no deaths that I know of. That was all that was needed to put the company out of business (may have been more I didn't know about) They want to CYA as much as possible, I'm sure you will not be in any danger with refurbished pumps.

Call them at 1-800-minimed if you have questions, they are open 24 hrs.