—#170858

Product

Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use with the MiniMed Paradigm Insulin Pump (MMT-523/723, MMT-523K/723K, MMT-551/751, MMT-554/754, MMT-522/722, MMT-522K/722K, MMT-515/715, MMT-512/712, MMT-511)

FDA product code: LZG — Pump, Infusion, Insulin
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K001829, K120206
Affected lot / code info: All serial numbers

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: Medtronic Inc.
Address: 18000 Devonshire St, Northridge, California 91325-1219

Distribution

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.

Timeline

Recall initiated: 2018-08-07
Posted by FDA: 2019-11-04
Terminated: 2024-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170858. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.