Insulin Pump Cybersecurity Vulnerability Allows Unauthorized Remote Access
MiniMed 600 series insulin pumps have a cybersecurity vulnerability that could allow unauthorized access, potentially resulting in delivery of too much or too little insulin. Users should disable the Remote Bolus feature.
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: This FDA Class II medical device recall involves a cybersecurity vulnerability that could lead to improper insulin dosing with serious health consequences. No illnesses or injuries have been reported. Per the severity rubric, a risk-of-harm product without reported injury scores at most 3 (High).
Plain-English summary
Medtronic has identified a cybersecurity vulnerability in MiniMed 600 series insulin pumps (models 620G and 640G). The vulnerability exists in the communication protocol used by these devices. Approximately 316,326 units have been distributed across the United States, U.S. territories, and multiple countries worldwide.
This vulnerability could allow unauthorized access to the insulin pump system. An unauthorized party could use this access to deliver too much or too little insulin by triggering an unintended insulin bolus or by slowing or stopping insulin delivery. Such unintended delivery could lead to dangerously high blood sugar (hyperglycemia) or dangerously low blood sugar (hypoglycemia).
Users of affected MiniMed 600 series insulin pumps should immediately disable the Remote Bolus feature to prevent unauthorized access to their device.
The recalled product
- Product
- Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
- Manufacturer
- Medtronic MiniMed
- Category
- Medical Device — Insulin Pump
- Hazard
- cybersecurity-vulnerability
- unauthorized-access
- unintended-bolus
- hypoglycemia
- hyperglycemia
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 (20)
- Model/UDI-GTIN (All Serial Numbers): MMT-1750/00763000375461
- 00643169559745
- MMT-1711/643169554931
- 763000367039
- 00643169890039
- 00643169554917
- 00643169629813
- 00643169554924
- 00643169554931
- 00643169742062
- 00763000013066
- 00643169554948
- 00643169554955
- 00643169621954
- MMT-1712/643169662612
- 643169577701
- 00763000205409
- 00643169890046
- 00643169577664
- 00643169629820
Distribution
Distributed in 54 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- GU
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VI
- VT
- WA
- WI
- WV
- WY
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