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.
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 medical device with a potential security vulnerability, which poses a risk of harm to patients using insulin pumps. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
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.
- Hazard
- 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.
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