CONTOUR® NEXT LINK 2.4 6262Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00301936262013), received between Jun 12, 2018 and Oct 9, 2023 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (5 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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2023Missing 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. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895318 ↗
• InjuryJul 18, 2023High Readings; High Readings

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THE BLOOD GLUCOSE READINGS OBTAINED ON THE CONTOUR NEXT LINK 2.4 METER WERE NOT IN AGREEMENT WITH THE SYMPTOMS. NO SPECIFIC READINGS WERE PROVIDED ASSOCIATED WITH THE EVENT. AROUND 2 MONTHS AGO, THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA WHICH WAS DESCRIBED AS BEING CONFUSED AND DIZZY. THE CUSTOMER FAINTED AND BROKE HER PELVIS BONE. IT IS UNKNOWN IF THE CUSTOMER PERFORMED A BLOOD GLUCOSE TESTING WITH THE CONTOUR NEXT LINK 2.4 METER PRIOR TO THE EVENT. HOWEVER, THE READING ON THE CUSTOMER'S INSULIN PUMP WAS 40 MG/DL. THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE HER BLOOD GLUCOSE LEVELS WERE CONSTANTLY MONITORED AND SHE WAS TREATED FOR THE BROKEN PELVIS. NO TREATMENT DETAILS WERE PROVIDED. THE CUSTOMER WAS HOSPITALIZED FOR TWO MONTHS AND HAS RECOVERED WELL. SINCE THE STRIP INFORMATION PROVIDED WAS NOT ASSOCIATED WITH THE EVENT, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: Confusion/ Disorientation; Dizziness; Hip Fracture; Syncope/Fainting

  MAUDE report 17341777 ↗
• InjuryApr 11, 2023High Readings; High Readings

  THE CUSTOMER ALLEGED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 700 MG/DL AND 70 MG/DL WITH THE CONTOUR NEXT LINK 2.4 METER. THE CONTOUR NEXT LINK 2.4 METER HAS THE HIGHEST MEASUREMENT RANGE OF 600 MG/DL. THE READINGS ABOVE 600 MG/DL WILL BE DISPLAYED AS HI READINGS IN THE METER. THE CUSTOMER STATED THAT HE WAS HOSPITALIZED BECAUSE HE EXPERIENCED HYPOGLYCEMIA. HOWEVER, THE CUSTOMER WAS TREATED WITH ANTIBIOTICS AND CONTINUOUS INSULIN DRIP IN THE HOSPITAL WHICH IS A TREATMENT FOR HYPERGLYCEMIA. THE BLOOD GLUCOSE TEST PERFORMED IN THE HOSPITAL PRODUCED A READING OF 110 MG/DL. NO FURTHER EVENT DETAILS WERE PROVIDED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: Hypoglycemia

  MAUDE report 16714501 ↗
• MalfunctionApr 7, 2021Missing Test Results; Missing Test Results

  THE ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT 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 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 11628649 ↗
• MalfunctionMay 22, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED A BLOOD GLUCOSE TEST ON A DIFFERENT METER AT 6:30 A.M. AND OBTAINED A READING OF 92 MG/DL. UPON REPEAT TESTING AT 6:31 A.M. ON THE CONTOUR NEXT LINK 2.4 METER, A READING OF 200 MG/DL WAS OBTAINED. 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: No Known Impact Or Consequence To Patient

  MAUDE report 10083021 ↗
• MalfunctionFeb 24, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE WAS AT THE HOSPITAL DUE TO HER DIABETES. THE CUSTOMER STATED THAT THE HOSPITAL VISIT WAS NOT RELATED TO THE READINGS OF HER CONTOUR NEXT LINK 2.4 BLOOD GLUCOSE MONITORING SYSTEM. WHILE AT THE HOSPITAL, THE CUSTOMER PERFORMED A BLOOD GLUCOSE TESTING USING HER CONTOUR NEXT LINK 2.4 METER AND OBTAINED A READING OF 345 MG/DL. BASED ON THIS READING, THE CUSTOMER RECEIVED 2.5 UNITS OF INSULIN FROM HER INSULIN PUMP. WITHIN 10 MINUTES, A REPEAT TESTING WAS PERFORMED WITH THE HOSPITAL'S METER AND A READING OF 135 MG/DL WAS OBTAINED. THREE HOURS LATER, THE CUSTOMER WAS FEELING UNWELL AND HAD HEADACHE, WHICH SHE RELATED WITH THE SYMPTOMS OF HYPOGLYCEMIA. THE CUSTOMER TOOK GLUCOSE AND RECOVERED WELL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: Headache; Hypoglycemia

  MAUDE report 9745240 ↗
• MalfunctionFeb 20, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE COMPARED HIS BLOOD GLUCOSE READINGS BETWEEN THE CONTOUR NEXT LINK 2.4 METER AND ANOTHER METER AND OBTAINED A DIFFERENCE OF 120 MG/DL. 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: No Known Impact Or Consequence To Patient

  MAUDE report 9731885 ↗
• MalfunctionFeb 20, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE COMPARED HIS BLOOD GLUCOSE READINGS BETWEEN THE CONTOUR NEXT LINK 2.4 METER AND ANOTHER METER AND OBTAINED A DIFFERENCE OF 120 MG/DL. 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: No Known Impact Or Consequence To Patient

  MAUDE report 9731883 ↗
• MalfunctionNov 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT WITHIN 3 MINUTES SHE OBTAINED A DIFFERENCE OF 30 MG/DL BETWEEN THE BLOOD GLUCOSE READINGS OBTAINED ON THE CONTOUR NEXT LINK 2.4 METER AND A NON-ASCENSIA METER. NO SPECIFIC READINGS WERE PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9376796 ↗
• MalfunctionSep 20, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER IN (B)(6) REPORTED BEING UNABLE TO SELECT THE GERMAN LANGUAGE ON THEIR CONTOUR NEXT LINK 2.4 BLOOD GLUCOSE METER. THE CUSTOMER REPORTED THAT THE METER WAS ONLY SHOWING ENGLISH AND SPANISH LANGUAGES. THE CUSTOMER WAS ABLE TO PERFORM A BLOOD GLUCOSE TEST. NO TREATMENT CHANGE WAS MADE AND THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER HAS BEEN REQUESTED TO RETURN THE TEST STRIPS AND METER FOR INVESTIGATION. REPLACEMENT STRIPS AND METER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9097904 ↗
• MalfunctionApr 1, 2019Missing Test Results; Missing Test Results

  THE CUSTOMER STATED 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 METER FOR EVALUATION. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8468742 ↗
• MalfunctionJun 12, 2018Missing Test Results; Missing Test Results

  THE ADVOCATE STATED HIS DAUGHTER'S CONTOUR NEXT LINK 2.4 WAS NOT SAVING ALL OF THE BLOOD GLUCOSE READINGS IN MEMORY. THE DAUGHTER TESTS HER BLOOD GLUCOSE 4 TIMES A DAY, BUT THE METER MEMORY SHOWS ONLY 1 READING PER DAY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE METER FOR EVALUATION A NEW METER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7590992 ↗
• MalfunctionJun 12, 2018Missing Test Results; Missing Test Results

  THE CUSTOMER STATED HIS CONTOUR NEXT LINK 2.4 WAS NOT SAVING ALL OF THE BLOOD GLUCOSE READINGS IN MEMORY. HIS INSULIN PUMP HAD AT LEAST 3 READINGS IN MEMORY THAT WERE SENT BY THE METER, BUT WERE NOT FOUND IN THE METER MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION A NEW METER WAS SENT TO THE HIM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7590956 ↗

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, Classified
  MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
• Z-1740-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• Z-1742-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
• Z-1739-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
• Z-1261-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
• Z-1265-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
• Z-1266-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
• Z-1259-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• Z-0003-2025 · Jul 31, 2024 · Open, Classified
  MiniMed 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, Classified
  MiniMed 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, Classified
  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-0855-2022 · Jan 27, 2022 · Open, Classified
  MiniMed 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, Classified
  MiniMed 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-0516-2021 · Apr 30, 2020 · Open, Classified
  MiniMed 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
• Z-0517-2021 · Apr 30, 2020 · Open, Classified
  MiniMed 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

…and 7 more.