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View Full Version : Minimed has just recalled *ALL* pumps


rickst29
07-13-2007, 03:25 PM
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

Abby-Dabby-Doo
07-13-2007, 03:35 PM
I only understood this to be if you've had an MRI while wearing the pump?!

We received a letter from the company (MM) informing us.

rickst29
07-13-2007, 03:46 PM
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.