FDAClass INovember 13, 2019

Minimed recall

Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL…

Why was Minimed recalled?

There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All serial numbers

Product
Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL…
Recalling firm
Medtronic Inc.
Quantity
90,213
Distribution
Distribution was nationwide to consumers and distributors. There was no government/military distribution. Foreign distribution was made to Algeria, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Martinique, Namibia, Netherlands, New Caledonia, Norway, Oman, Pakistan, Poland, Reunion, Romania, Russian Federation, Saudi Arabia, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, and United Kingdom.
Recall date
November 13, 2019
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls