Agency classClass IOur severity:Severe FDA (Devices)·Z-0177-2020·Announced 2019-11-13

Medtronic Recalls MiniMed Model 500 Remote Controls for Security Vulnerability

Medtronic is recalling MiniMed Model 500 Remote Controls used with the MiniMed 508 Insulin Pump due to a potential security vulnerability.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps."

Plain-English summary

Medtronic Inc. is recalling the MiniMed Model 500 Remote Control (MMT-500 and various regional variants) for use with the MiniMed 508 Insulin Pump. The recall involves 90,213 units distributed nationwide to consumers and distributors, as well as to numerous 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 who have these remote controls should contact Medtronic for further instructions on how to address the security vulnerability.

The recalled product

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).
Manufacturer: Medtronic Inc.
Category: Medical Device — Insulin Pump Accessories
Hazard: security-vulnerability
Affected units: 90,213

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 →

Same manufacturer · Medtronic Inc.

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