The Recall Desk
HighFDA (Devices)·Z-0178-2020·Announced 2019-11-13

Medtronic Recalls MiniMed Remote Transmitters for Security Vulnerability

Medtronic is recalling MiniMed Model 503 Remote Transmitters due to a potential security vulnerability affecting insulin pump accessories.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a potential security vulnerability in a medical device (insulin pump accessory) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without confirmed harm.

Plain-English summary

Medtronic Inc. is recalling the MiniMed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) used with MiniMed Paradigm Insulin Pumps. The recall involves 141,519 units distributed nationwide to consumers and distributors, as well as to various foreign countries.

The recall is being conducted because there is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps. The source text does not specify the nature of the security risk or any reported injuries or illnesses.

Consumers should contact Medtronic for further instructions on how to address the security vulnerability. The source text does not provide specific remediation steps or a deadline for action.

The recalled product

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)
Manufacturer
Medtronic Inc.
Affected units
141,519

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Medtronic Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →