Recall Weekly
Serious riskFDA DeviceClass II

Medtronic MiniMed Paradigm pumps recalled for insulin delivery risk

Medtronic MiniMed insulin pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin depending on whether the pump is positioned higher or lower than your infusion site. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar and other serious complications.

From the FDA notice · Read the official notice ↗ · All Medtronic recalls

What to do

  1. Contact Medtronic immediately to check if your pump is affected
  2. Do not change your pump's position relative to your infusion site
  3. Monitor your blood sugar closely and watch for signs of high or low blood sugar
  4. Talk to your doctor about alternative insulin delivery options while this is resolved
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Paradigm Insulin Pump (MMT-712, MMT-715)
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 14 products — see all of them.

Details

Units affected
73,656
Illnesses reported
None reported
Manufactured in
18000 Devonshire St, Northridge, CA, United States
Classification
Class II
Recall number
Z-1748-2026

In the FDA's words

Description
Paradigm Insulin Pump (MMT-712, MMT-715) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. Pump: UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Insulin Pump: 643169999770, 643169729360, 763000065201, 763000069001, 763000192228, 763000198602, 763000155346, 763000192143, 763000258344, 763000317140, 763000404567, 763000317188, 763000317195, 763000367046, 763000317157, 00613994470492, 00643169496262, 643169577664, 643169577688, 643169577695, 643169739512, 00613994332929, 00613994469694, 00613994470904, 00763000084271, 00763000161019, 643169577701, 643169739512, 643169662612, 00643169533776, 00763000084370, 643169656840, 763000090197, 763000190439, 763000316631, 00613994473820, 00643169478503, 00613994151766, 00643169710368, 00763000161057, 00613994326478, 00613994326508, 00613994395771, 00613994395719, 00613994395696, 00613994527851, 00643169729421, 00643169198920, 00643169572447, 00643169198890, 00613994527868, 00613994172129, 00613994172419, 00613994171627, 00613994171344, 00613994172211, 00613994172525, 00613994172334, 00613994172044, 00613994172761, 00613994171917, 00613994326621, 00613994326584, 00643169848825, 00643169848832, 00643169848801, 00613994395818, 00613994395764, 00613994395740, 00613994394132, 00763000069209, 00763000069179, 00613994527905, 00763000069162, 00613994527769, 00613994405876, 00763000069186, 00763000069148, 00613994527783, 00613994527806, 00613994527899, 00613994527790, 00613994527882, 00613994527837, 00643169198968, 00643169198883, 00643169198944, 00643169198906, 00763000084301, 00613994527745, 00643169198975, 00643169035515, 00643169201927, 00643169198913, 00643169198937, 00613994475268, 00643169198999, 00643169198982, 00643169503120, 00763000187507, 00643169198951, 00643169848818, 00643169848795, 00643169848771, 00613994527738, 00613994171443, 00613994171528, 00613994326539, 00613994326560, 00613994395726, 00613994395757, 00763000102616, 00763000069155, 00613994473868, 00763000004262, 00763000084318, 00763000161064, 76300031665503, 763000316655, 643169656840, 763000367053, 763000090197, 763000166519, 763000072520, 763000190439, 76300031665501, 763000316631, 763000256807: INSTR,US,FINE TUNING,PUMP,512/712 (6024948-012 3); INSTR,US,FINE TUNING,PUMP,PRDGM (6024948-013 1); INSTR,EN,FINE TUNING,PUMP (6024948-021 3); INSTR,US,PUMPS,PRDGM,515/715 (6025020-017 1); INSTR., 515/715, PRDGM, US (6025020-018 2); INSTR, 515/715, MDD, EN (6025020-024 1); INSTR, 515/715, EURO-E, MDD (6025020-025 2); INSTR., X15, EN OUS (6025020-026 1) Distribution: Worldwide - US Nationwide distribution including in the states of OR, CA, AZ, NY,TX,FL, OH, MO, TN,NJ, NC, SC, IL, VA, WA, DC, GA, PA, MS,IA, MI, NH, OK, SD, MT, WI, WV, MA, LA, MN, RI, AR, ME, AL, IN, UT, KY, CO, ND, MD, CT, NM, KS, ID, NV, DE, NE, VT, AK, HI, WY, PR, VI and the countries of Taiwan, New Zealand, Australia, Bangladesh, Brunei Darussalam, Cambodia, Indonesia, Malaysia, Maldives, Philippines, Thailand, Vietnam, Singapore, Pakistan, Hong Kong, China, Argentina, Aruba, Barbados, Bermuda, Bolivia, Plurinational State Of, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Panama, Paraguay, Peru, Puerto Rico, Trinidad And Tobago, Uruguay, Venezuela, Canada, South Korea, India, Albania, Algeria, Andorra, Armenia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Bulgaria, Canary Islands, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guyana, French Polynes., Georgia, Germany, Gibraltar, Greece, Guadeloupe, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Macedonia, Malawi, Malta, Martinique, Mauritius, Mayotte, Moldavia, Montenegro, Morocco, Namibia, Netherlands, New Caledonia, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Qatar, Reunion, Romania, Russia, San Marino, Saudi Arabia, Serbia, Sierra Leone, Slovakia, Slovenia, South Africa, Spain, St.Pier,Miquel., Sudan, Sweden, Switzerland, Syrian Arab Republic, Tanzania, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Yemen, Zambia, Zimbabwe. Affected quantity: 73,656
Hazard
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

14 products in this recall

Medtronic MiniMed insulin pumps recalled for dosing error risk

Medtronic is recalling 14 MiniMed insulin pump models, including the Paradigm, 600 series, and BLE 700 series. Changes in pump height relative to the infusion site can cause the pump to deliver too much or too little insulin. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

More from Medtronic

See all

Related topics

OtherMedical devicesSold nationwideMore from FDA Device