Medtronic MiniMed Insulin Pumps Recalled for Cybersecurity Vulnerability
Medtronic is recalling MiniMed 630G and 670G insulin pumps due to a cybersecurity vulnerability that could allow unauthorized access to the pump system, potentially resulting in incorrect insulin delivery.
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 recall is scored as High because it affects risk-of-harm products (life-critical insulin delivery devices) with serious potential consequences. However, no reported injuries or hospitalizations have occurred, placing it below the Severe threshold that would require reported harm.
Plain-English summary
Medtronic MiniMed is recalling approximately 399,651 MiniMed 630G and MiniMed 670G insulin pump models worldwide. The recall was issued due to a cybersecurity vulnerability in the pump's communication protocol.
The vulnerability could allow unauthorized access to the insulin pump system. An attacker with such access could deliver too much insulin through an unintended insulin bolus, or cause insulin delivery to be slowed or stopped, potentially leading to low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia).
The affected pumps were distributed throughout the United States and multiple international locations including Canada, Australia, Mexico, and numerous other countries.
To reduce risk, Medtronic recommends turning off the Remote Bolus feature on affected insulin pumps. Users should contact Medtronic or their healthcare provider with any questions or concerns about their device.
The recalled product
- Product
- Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742
- Manufacturer
- Medtronic MiniMed
- Category
- Medical Device — Insulin Pump
- Hazard
- cybersecurity-vulnerability
- insulin-overdose
- insulin-underdose
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-1715/643000000000
- 763000072520
- 643169873834
- 00643169656840
- MMT-1755/643169752726
- 643169873841
- 643169878648
- 763000179632
- 00643169752726
- MMT-1754/643169976344
- MMT-1780/643169949706
- 643169939202
- 763000072537
- 643000000000
- 00643169939219
- MMT-1781/763000187415
- 763000283568
- 00763000140601
- 00763000225575
- 00763000235765
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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