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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90910

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 20, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic MiniMed

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-0193-2023
Recall number
Z-0193-2023
Initiated
September 20, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
399651

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerability

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump system. This unauthorized access could be used to deliver too much or too little insulin through delivery of an unintended insulin bolus or because insulin delivery is slowed or stopped, which could lead to hypoglycemia or hyperglycemia. The Remote Bolus feature on insulin pumps should be turned off to prevent the unauthorized access.

Code information

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, 00763000187415, 00763000283551, 00763000240707; MMT-1782/763000187422, 763000283599, 00763000140618, 00763000225612, 00763000235772, 00763000187422, 00643169957640, 00763000283582; MMT-1760/643169946040, 763000278427, 763000179649, 643169946057, 763000367084, 00643169946057; MMT-1761/00763000367657, 00763000165413; MMT-1762/00763000239404, 00763000203313, 00763000216481, 00763000187408, 00763000165475; MMT-1740/Investigational; MMT-1741/00763000303556, 00763000408916; MMT-1742/00763000250232

Distribution pattern

US: 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. OUS: Andorra, Australia, Austria, Barbados, Belgium, Bermuda, Bolivia, Botswana, Canada, Canary Islands, Cayman Islands, Chile, Czech Republic, Denmark, Dominican Rep., El Salvador, Faroe Islands, Finland, France, Germany, Gibraltar, Greece, Guatemala, Hungary, Ireland, Israel, Italy, Kenya, Liechtenstein, Luxembourg, Mauritius, Mexico, Namibia, Netherlands, New Zealand, Norway, Paraguay, Peru, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Trinidad and Tobago, Turkey, Uganda, United Kingdom, Venezuela

device · product 2 of 2

Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752

Z-0194-2023
Recall number
Z-0194-2023
Initiated
September 20, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
316326

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerability

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump system. This unauthorized access could be used to deliver too much or too little insulin through delivery of an unintended insulin bolus or because insulin delivery is slowed or stopped, which could lead to hypoglycemia or hyperglycemia. The Remote Bolus feature on insulin pumps should be turned off to prevent the unauthorized access.

Code information

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, 00643169577671, 00643169577688, 00763000155346, 00643169577695, 00643169577701, 00643169621961; MMT-1751/643169672239, 00643169574410, 00643169574427, 00643169574434, 00763000253288, 00643169574441, 00643169574458, 00643169643512, 00643169521155, 00643169521704, 00763000015596, 00643169520882, 00643169521421, 00643169521971; MMT-1752/763000192181, 00643169596368, 00643169596382, 00643169596405, 00763000318291, 00763000318307, 00643169596443, 00643169522305, 00643169521292, 00643169522381, 00643169521841, 00643169522268, 00643169521025, 00643169522343, 00643169521575, 00643169522114

Distribution pattern

US: 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. OUS: Andorra, Australia, Austria, Barbados, Belgium, Bermuda, Bolivia, Botswana, Canada, Canary Islands, Cayman Islands, Chile, Czech Republic, Denmark, Dominican Rep., El Salvador, Faroe Islands, Finland, France, Germany, Gibraltar, Greece, Guatemala, Hungary, Ireland, Israel, Italy, Kenya, Liechtenstein, Luxembourg, Mauritius, Mexico, Namibia, Netherlands, New Zealand, Norway, Paraguay, Peru, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Trinidad and Tobago, Turkey, Uganda, United Kingdom, Venezuela