CONTOUR® NEXT LINK 2.4 6260Recalls & reported problems
Ascensia Diabetes Care US Inc. · Wireless Blood Glucose Monitoring System. 1 Kit. For Self-testing of Diabetes. Kit Contains: CONTOUR® NEXT LINK 2.4 Blood Glucose Meter; 25 CONTOUR® NEXT Test Strips; Lancing Device; Alternative Site Endcap; 25 Lancets (provided sterile); User Guide; Quick Reference Guide; Lancing Device Insert; USB Cable; Wall Charger; Wall Charger Insert; Logbook and Carrying Case; CONTOUR® NEXT Level 2 control solution. · Class 3
All models of CONTOUR NEXT LINK 2.4 (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is an Ascensia CONTOUR NEXT LINK 2.4 blood glucose meter kit, used for self-testing at home. Most of the 74 reports describe the meter not saving readings to its memory, or giving readings that seemed too high, too low, or unclear, along with some wireless connection trouble. Ten reports involved injuries and no deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 74
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00301936260019), received between Dec 5, 2017 and May 1, 2025 — classified as 10 injuries, 64 malfunctions.
The most frequently reported specific device problem is “Missing Test Results” (45 reports).
22 other recalls cover devices cleared under the same FDA submission (P150001, P160017); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Missing Test Results45
- High Readings12
- Incorrect, Inadequate or Imprecise Result or Readings11
- Low Readings3
- Wireless Communication Problem2
- Fire1
- No Device Output1
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- No Known Impact Or Consequence To Patient29
- Hypoglycemia4
- Shaking/Tremors4
- Confusion/ Disorientation3
- Dizziness2
- Hyperglycemia2
- Bone Fracture(s)1
Recent adverse event reports
The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2025Missing Test Results; Missing Test Results
THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT LINK 2.4 METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER'S READINGS WERE NOT BEING STORED IN THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21942070 ↗MalfunctionFeb 4, 2025High Readings; High Readings
THE CUSTOMER REPORTED THAT HE PERFORMED BLOOD GLUCOSE TESTING WITH THE CONTOUR® NEXT LINK 2.4 METER AND OBTAINED READINGS OF 415 MG/DL, 111 MG/DL AND 400 MG/DL WITHIN 10 MINUTES. THE CUSTOMER WAS FEELING DIZZY AND CALLED AN EMERGENCY SERVICE. THE PARAMEDICS PERFORMED TESTING WITH THE CUSTOMER'S METER. NO SPECIFIC READING WAS PROVIDED. THE CUSTOMER TOOK ORANGE JUICE AND AFTER 40 MINUTES, ANOTHER TESTING WAS PERFORMED WITH THE PARAMEDICS' METER AND A READING OF 288 MG/DL WAS OBTAINED. THE CUSTOMER RECOVERED WELL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.
Patient problems: Dizziness
MAUDE report 21305626 ↗MalfunctionAug 21, 2024Missing Test Results; Missing Test Results
THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE THE CONTOUR NEXT LINK 2.4 METER. DURING TROUBLESHOOTING, IT WAS FOUND THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20017858 ↗MalfunctionSep 15, 2023Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 2.4 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17755387 ↗MalfunctionFeb 13, 2023Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 2.4 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16363480 ↗MalfunctionSep 29, 2022Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 2.4 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15502446 ↗MalfunctionJun 21, 2022Missing Test Results; Missing Test Results
THE CUSTOMER FROM (B)(6) REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 2.4 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14756088 ↗InjuryMay 24, 2022Low Readings; Low Readings
THE CUSTOMER REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE READING OF 271 MG/DL AT 2:01 P.M. WITH THE CONTOUR NEXT LINK 2.4 METER. THE CUSTOMER WAS EXPERIENCING SYMPTOMS SUCH AS NAUSEA AND DEHYDRATION. THE CUSTOMER TOOK 1 UNIT OF INSULIN BASED ON THE METER READING. SINCE THE CUSTOMER WAS FEELING UNWELL, SHE WENT TO THE HOSPITAL WHERE SHE STAYED FOR TWO DAYS AND RECOVERED WELL. IN THE HOSPITAL, ADDITIONAL BLOOD GLUCOSE TESTING WAS PERFORMED WITH THE CUSTOMER'S METER AND A NON-ASCENSIA METER, WHICH GAVE READINGS OF 278 MG/DL AT 2:23 P.M. AND 353 MG/DL AT 2:30 P.M. RESPECTIVELY. NO FURTHER EVENT DETAILS WERE PROVIDED. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.
Patient problems: Dehydration; Nausea
MAUDE report 14489516 ↗MalfunctionJan 12, 2022Missing Test Results; Missing Test Results
AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT SOME OF THEIR BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 2.4 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13235854 ↗InjurySep 14, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT SHE OBTAINED INACCURATE READINGS WITH THE CONTOUR NEXT LINK 2.4 METER. NO SPECIFIC READING FROM THE EVENT WAS PROVIDED. THE CUSTOMER STATED THAT SHE WAS EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA AND TOOK INSULIN. THE CUSTOMER FELT SICK AFTER ADMINISTERING INSULIN AND WENT TO THE HOSPITAL. THE CUSTOMER DECLINED TO PROVIDE ANY FURTHER EVENT DETAILS. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.
Patient problems: Hyperglycemia
MAUDE report 12468406 ↗InjurySep 14, 2021High Readings; High Readings
THE CUSTOMER REPORTED THAT HE CONSUMED THE REGULAR AMOUNT OF CARBOHYDRATE AND THEN PERFORMED A BLOOD GLUCOSE TEST WITH THE CONTOUR NEXT LINK 2.4 METER PRIOR TO GOING TO SLEEP AND HIS SUGAR LEVEL WAS FINE. NO SPECIFIC READING WAS PROVIDED. TWO HOURS LATER, THE CUSTOMER WOKE UP IN THE MIDDLE OF THE NIGHT AS HE WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA SUCH AS UNAWARENESS AND DIZZINESS, AND THEN HE FAINTED. WHEN THE CUSTOMER FAINTED, HE FELL DOWN A FLIGHT OF STAIRS. THE EMERGENCY SERVICE WAS CALLED AND THE CUSTOMER WAS TAKEN TO THE HOSPITAL. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 35 MG/DL. THE CUSTOMER WAS GIVEN GLUCOSE INTRAVENOUSLY. THE CUSTOMER HAD ALSO BROKEN HIS ANKLE WHEN HE FELL DOWN THE STAIRS AND A CAST WAS PLACED ON HIS ANKLE. THE CUSTOMER'S INSULIN PUMP WAS REMOVED AND FOR 5 DAYS HE WAS GIVEN INSULIN THROUGH INJECTIONS. 5 DAYS LATER, THE CUSTOMER WAS REPORTED TO BE EXPERIENCING CONFUSION. THE CUSTOMER WAS BEING MONITORED AND CONTINUED TO RECEIVE INTRAVENOUS GLUCOSE. THE CUSTOMER WAS HOSPITALIZED FOR 7 DAYS AND RECOVERED WELL. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PR
Patient problems: Bone Fracture(s); Confusion/ Disorientation; Dizziness; Hypoglycemia; Syncope/Fainting
MAUDE report 12468405 ↗MalfunctionSep 1, 2021Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 2.4 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12406332 ↗MalfunctionJun 15, 2021Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 2.4 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11998312 ↗InjuryJun 3, 2021Low Readings; Low Readings
THE CUSTOMER REPORTED THAT THEIR CONTOUR NEXT LINK 2.4 METER GAVE INACCURATE READINGS. THE CUSTOMER HAD AN EVENT OF KETOACIDOSIS. THE CUSTOMER WENT TO AN EMERGENCY ROOM OF A HOSPITAL, WHERE THEY WERE GIVEN ANTIBIOTICS AND INSULIN INJECTION. THE CUSTOMER STATED THAT WHILE AT THE HOSPITAL, THEY PERFORMED COMPARISON OF BLOOD GLUCOSE RESULTS BETWEEN THE CONTOUR NEXT LINK 2.4 METER AND THE PHYSICIAN'S METER RECEIVING READINGS OF 250 MG/DL AND 470 MG/DL RESPECTIVELY. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 11929466 ↗MalfunctionJun 3, 2021Missing Test Results; Missing Test Results
AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THEIR BLOOD GLUCOSE WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 2.4 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11929464 ↗MalfunctionMay 26, 2021Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 2.4 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11885446 ↗MalfunctionMay 25, 2021Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 2.4 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11877605 ↗MalfunctionApr 20, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
AN ADVOCATE CALLED ON BEHALF OF HER DAUGHTER TO REPORT THAT THEY PERFORMED BLOOD GLUCOSE TEST WITH THEIR CONTOUR NEXT LINK 2.4 METER. THE METER AUTOMATICALLY MARKED IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A CONTROL RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE ADVOCATE. SINCE THE STRIP INFORMATION PROVIDED BY THE ADVOCATE IS NOT ASSOCIATED WITH THE EVENT, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11693339 ↗MalfunctionApr 20, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
AN ADVOCATE CALLED ON BEHALF OF HER DAUGHTER TO REPORT THAT THEY PERFORMED BLOOD GLUCOSE TEST WITH THEIR CONTOUR NEXT LINK 2.4 METER. THE METER AUTOMATICALLY MARKED IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A CONTROL RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE ADVOCATE. SINCE THE STRIP INFORMATION PROVIDED BY THE ADVOCATE IS NOT ASSOCIATED WITH THE EVENT, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11693334 ↗MalfunctionApr 20, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
AN ADVOCATE CALLED ON BEHALF OF HER DAUGHTER TO REPORT THAT THEY PERFORMED BLOOD GLUCOSE TEST WITH THEIR CONTOUR NEXT LINK 2.4 METER. THE METER AUTOMATICALLY MARKED IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A CONTROL RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE ADVOCATE. SINCE THE STRIP INFORMATION PROVIDED BY THE ADVOCATE IS NOT ASSOCIATED WITH THE EVENT, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11693333 ↗MalfunctionApr 20, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
AN ADVOCATE CALLED ON BEHALF OF HER DAUGHTER TO REPORT THAT THEY PERFORMED BLOOD GLUCOSE TEST WITH THEIR CONTOUR NEXT LINK 2.4 METER. THE METER AUTOMATICALLY MARKED IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A CONTROL RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE ADVOCATE. SINCE THE STRIP INFORMATION PROVIDED BY THE ADVOCATE IS NOT ASSOCIATED WITH THE EVENT, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11693332 ↗MalfunctionApr 14, 2021Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 2.4 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11665019 ↗MalfunctionApr 7, 2021Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 2.4 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11628645 ↗MalfunctionMar 16, 2021Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 2.4 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE CUSTOMER DECLINED THE OFFER FOR THE REPLACEMENT DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11493806 ↗MalfunctionFeb 17, 2021Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT ONE OF HIS BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT LINK 2.4 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11338219 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P150001, P160017. One submission often covers many models, so check the product and lot details in each record.
- Z-2981-2026 · Jul 13, 2026 · Open, ClassifiedMiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
- Z-1742-2026 · Feb 13, 2026 · Open, ClassifiedMiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
- Z-1739-2026 · Feb 13, 2026 · Open, ClassifiedMiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
- Z-1740-2026 · Feb 13, 2026 · Open, ClassifiedMiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
- Z-1259-2025 · Jan 31, 2025 · Open, ClassifiedMiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
- Z-1261-2025 · Jan 31, 2025 · Open, ClassifiedMiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
- Z-1266-2025 · Jan 31, 2025 · Open, ClassifiedMiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
- Z-1265-2025 · Jan 31, 2025 · Open, ClassifiedMiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
- Z-0003-2025 · Jul 31, 2024 · Open, ClassifiedMiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G
- Z-0001-2025 · Jul 31, 2024 · Open, ClassifiedMiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
- Z-0193-2023 · Sep 20, 2022 · Open, ClassifiedInsulin 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-0855-2022 · Jan 27, 2022 · Open, ClassifiedMiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-18
- Z-1771-2021 · Mar 15, 2021 · Open, ClassifiedMiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL; PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL; KIT MMT-1896WW MM780G 6.5W BLE
- Z-0517-2021 · Apr 30, 2020 · Open, ClassifiedMiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rate
- Z-0516-2021 · Apr 30, 2020 · Open, ClassifiedMiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under
…and 7 more.
Other Artificial Pancreas Device System, Threshold Suspend devices
- t:slim X2 Insulin Pump with Basal-IQ 1000886Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall17 deaths108,656 reports
- MiniMed® 630G MMT-1715KMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend4 recalls98 deaths35,170 reports
- t:slim X2 Insulin Pump with Basal-IQ 1000912Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall2 deaths30,219 reports
- t:slim X2 Insulin Pump with Basal-IQ 1000898Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall6 deaths16,106 reports
- MiniMed® 630G MMT-1715KMMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend2 recalls50 deaths9,892 reports
- MiniMed® 630G MMT-1715KMedtronic Minimed, Inc. · Automated insulin dosing , threshold suspend4 recalls36 deaths7,947 reports
- MiniMed® 530G MMT-751NASMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend36 deaths7,479 reports
- MiniMed®630G MMT-1715KMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend2 recalls17 deaths6,645 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page