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Recall Observatory FDA recall evidence

Device 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, MMT-500RNL) for use with the MiniMed 508 Insulin Pump (MMT-508).

Z-0177-2020

August 07, 2018

Class I

Product summary

Firm
Medtronic Inc.
Event
Event 82078
Status
Terminated
Classification
Class I
Quantity
90,213
Official record key
device-enforcement:Z-0177-2020

Official wording

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

Code information: All serial numbers

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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