Z-0177-2020Class I

Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE...

Name: Z-0177-2020 Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE...
Creator: Medtronic Inc.
Published: 2018-08-07
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-08-07 / Terminated / root cause: software

FDA source

Medtronic Inc. began a recall of 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... on 2018-08-07. FDA classified it as Class I and gives the reason as "There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0177-2020
Classification: Class I
Status: Terminated
Initiated: 2018-08-07
Posted: 2019-11-04
Terminated: 2024-03-29
Recalling firm: Medtronic, Inc.
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).
Product code: LZG Pump, Infusion, Insulin
Reason for recall: There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
Root cause tag: software
FDA root cause: Software design
Action: Medtronic sent an Urgent Field Safety Notification letter dated August 7, 2018 to the patient, distributor, and healthcare provider via email, U.S. mail, or phone. The letter identified the affected product, problem and actions to be taken. Starting on 10/05/2021, recall notices were sent to patients, health care professionals, distributors, and personnel at clinical sites. Distributors were asked to provide their customer lists to the recalling firm so the recalling firm could send customers recall notices. The scope of the recall is being expanded to all users regardless of warranty status. Users are asked to stop using and disconnect the remote controller, disable the remote feature, and return the remote controller to the recalling firm. Customers were also asked to provide the information requested in the confirmation form to the recalling firm via phone, mail, email, or online on the firm's website. Additional questions can be directed to Technical Support at 1-800-378-2292. Disconnecting/Disabling instructions were provided in the recall notice, which provided the following link: https://info.medtronicdiabetes.com/remote-controller-return
Quantity in commerce: 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.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0177-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0177-2020	Class I	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-04
Z-0178-2020	Class I	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-04

Product code LZG

K990801Class IIMinimed 508 Insulin PumpMedtronic Minimed / cleared 1999-06-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)