CONTOUR® NEXT 7309Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10301937309509), received between Jun 2, 2017 and Aug 23, 2024 — classified as 11 injuries, 26 malfunctions.

The most frequently reported specific device problem is “High Readings” (17 reports).

23 other recalls cover devices cleared under the same FDA submission (K121190, K160430, K162336, K191286, K193407, K210687, K223293, K241787, 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 38 MG/DL AT 9:06 P.M. AND 263 MG/DL AT 9:09 P.M. WITH 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 20056855 ↗
• MalfunctionJan 11, 2023Low Readings; Low Readings

  THE CUSTOMER FROM FRANCE CALLED ASCENSIA CUSTOMER SERVICE TO REPORT AN ISSUE WITH THEIR CONTOUR NEXT METER. DURING THE CALL, THREE LIVE TESTS WERE PERFORMED WITH THE METER AND READINGS OF 253 MG/DL AT 2:32 P.M., 48 MG/DL AT 2:33 P.M. AND 279 MG/DL AT 2:34 P.M. WERE OBTAINED. THERE IS 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 16137300 ↗
• MalfunctionJan 4, 2023Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT SHE ATE A SANDWICH AFTER WHICH SHE PERFORMED BLOOD GLUCOSE TESTING WITH THE CONTOUR NEXT METER AND OBTAINED READINGS OF 20 MG/DL AT 9:28 P.M. AND 413 MG/DL AT 9:36 P.M. THE CUSTOMER TOOK 15 UNITS OF NOVALOG INSULIN BASED ON THE HIGH READING. 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 16094374 ↗
• MalfunctionDec 6, 2022Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 568 MG/DL AT 10:10 P.M. AND 146 MG/DL AT 10:11 P.M. WITH THE CONTOUR NEXT LINK 2.4 METER. THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA WHICH WERE DESCRIBED AS HEADACHE, THIRSTY AND TIRED. THE CUSTOMER STATED THAT SHE TOOK 40 UNITS OF ADDITIONAL INSULIN AND FELT BETTER. 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: Headache; Hyperglycemia

  MAUDE report 15924050 ↗
• MalfunctionSep 1, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE PERFORMED A BLOOD GLUCOSE TEST AND OBTAINED A READING OF 256 MG/DL AT 11:49 A.M. WITH THE 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 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 15335802 ↗
• InjuryJun 6, 2022High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 346 MG/DL AT 9:08 A.M. AND 188 MG/DL AT 11:16 A.M. WITH THE CONTOUR NEXT LINK 2.4 METER. THE CUSTOMER TOOK INSULIN BASED ON THE HIGH READINGS. THE CUSTOMER THEN ATE CANDY TO MANAGE THE BLOOD GLUCOSE LEVELS AND PASSED OUT. THE CUSTOMER STATED THAT WHEN SHE WOKE UP HER BLOOD GLUCOSE LEVELS WERE NORMAL. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: Loss of consciousness

  MAUDE report 14602888 ↗
• InjuryAug 11, 2021High Readings; High Readings

  THE CUSTOMER CALLED TO REPORT THAT HE OBTAINED A BLOOD GLUCOSE READING OF 130 MG/DL WITH THE CONTOUR NEXT LINK METER. THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA SUCH AS BEING COLD, SWEATING AND THEN HE BECAME UNCONSCIOUS. THE CUSTOMER'S DAUGHTER CALLED AN AMBULANCE. UPON THE ARRIVAL OF THE AMBULANCE, THEY PERFORMED A TESTING WITH THEIR METER AND OBTAINED A READING OF 50 MG/DL. THE CUSTOMER WAS GIVEN A GLUCAGON INJECTION AND TAKEN TO AN EMERGENCY ROOM. IT IS UNKNOWN IF AN ADDITIONAL TESTING WAS PERFORMED OR IF AN ADDITIONAL TREATMENT WAS PROVIDED IN THE EMERGENCY ROOM. THE CUSTOMER RECOVERED WELL. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 12306784 ↗
• MalfunctionMar 18, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF BELOW 20 MG/DL AND 127 MG/DL AT 08:54 A.M. ON THE CONTOUR NEXT LINK 2.4 METER. THE CUSTOMER DID NOT EXPERIENCE SYMPTOMS OF HYPOGLYCEMIA. 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 11515338 ↗
• MalfunctionFeb 17, 2021Low Readings; Low Readings

  AN ADVOCATE CALLED ON BEHALF OF HER SON TO REPORT THAT THEY OBTAINED BLOOD GLUCOSE READINGS OF LO (INDICATIVE OF A READING BELOW 20 MG/DL) AT 10:32 P.M. AND 97 MG/DL AT 10:34 P.M. ON THE CONTOUR NEXT LINK 2.4 METER. THE CUSTOMER DID NOT EXPERIENCE ANY SYMPTOMS OF HYPOGLYCEMIA. 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 ADVOCATE.

  Patient problems: Hypoglycemia

  MAUDE report 11338217 ↗
• InjuryDec 7, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 53 MG/DL AND 38 MG/DL AT 6:54 P.M. AND 32 MG/DL AT 6:58 P.M. ON THE CONTOUR NEXT LINK 2.4 METER. THE CUSTOMER STATED THAT SHE HAD A HEADACHE, HOWEVER, SHE IS HYPOGLYCEMIC UNAWARE. THE CUSTOMER DRANK JUICE AFTER WHICH SHE RECOVERED WELL. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: Headache

  MAUDE report 10958934 ↗
• InjuryNov 19, 2020High Readings; High Readings

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

  Patient problems: Confusion/ Disorientation; Hypoglycemia; Loss of consciousness

  MAUDE report 10869361 ↗
• MalfunctionSep 8, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT A MONTH AGO THERE WAS A DIFFERENCE OF 50 MG/DL BETWEEN THE BLOOD GLUCOSE READINGS OBTAINED ON TWO SEPARATE CONTOUR NEXT LINK 2.4 METERS AND THE CONTOUR NEXT LINK METER. NO SPECIFIC READINGS WERE PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KITS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10503433 ↗
• MalfunctionFeb 7, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE PERFORMED COMPARISON TESTING BETWEEN BLOOD GLUCOSE READINGS ON THE CONTOUR NEXT LINK 2.4 METER AND THE PHYSICIAN'S METER. AT 2:32 P.M. AND 2:34 P.M., THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 228 MG/DL ON THE CONTOUR NEXT LINK 2.4 METER. ANOTHER TESTING WAS PERFORMED WITH THE PHYSICIAN'S METER AT 2:40 P.M. AND A READING OF 120 MG/DL WAS OBTAINED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE PRODUCT FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9680862 ↗
• InjuryFeb 4, 2020High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED A HIGH READING ON THE CONTOUR NEXT LINK 2.4 METER. NO SPECIFIC READING WAS PROVIDED. THE CUSTOMER ALSO HAD HER MEAL. ACCORDING TO HER PHYSICIAN'S PRESCRIPTION OF BASED ON HIGH READING, SHE TOOK ADDITIONAL 50 UNITS OF NOVOLOG INSULIN BOLUS. THE CUSTOMER WAS FEELING WELL. AROUND TWO HOURS LATER, THE CUSTOMER STARTED EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA SUCH AS SWEATING AND THEN BECAME UNCONSCIOUS. THE CUSTOMER'S HUSBAND GAVE HER CANDIES BUT SHE WAS NOT RESPONSIVE, SO THE CUSTOMER'S HUSBAND CALLED PARAMEDICS. UPON THE ARRIVAL OF PARAMEDICS, THEY CHECKED CUSTOMER'S GLUCOSE LEVELS WITH THEIR METER AND OBTAINED A READING OF 26 MG/DL. THE PARAMEDICS GAVE INTRAVENOUS SUGAR SOLUTION TO THE CUSTOMER, AFTER WHICH SHE RECOVERED WELL. HER BLOOD GLUCOSE WAS MEASURED AGAIN AND IT WAS UP TO 113 MG/DL. THE CUSTOMER WAS ADVISED TO RETURN THE PRODUCT FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: Loss of consciousness; Sweating

  MAUDE report 9666408 ↗
• MalfunctionJan 13, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE RECEIVED A DIFFERENCE OF 100 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 CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9581876 ↗
• MalfunctionDec 17, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED A DIFFERENCE OF 30-40 MG/DL BETWEEN BLOOD GLUCOSE READINGS OBTAINED ON TWO SEPARATE CONTOUR NEXT LINK METERS. NO SPECIFIC READINGS WERE PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9481666 ↗
• MalfunctionNov 21, 2019Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT HE OBTAINED A BLOOD GLUCOSE READING OF 136 MG/DL ON THE CONTOUR NEXT LINK 2.4 METER. HE PERFORMED REPEAT TESTING WITH HIS DOCTOR'S METER WITHIN 2 MINUTES AND OBTAINED A READING OF 283 MG/DL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9353952 ↗
• MalfunctionNov 20, 2019Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE READING OF 114 MG/DL ON THE CONTOUR NEXT LINK 2.4 METER. SHE PERFORMED REPEAT TESTING WITHIN 10 MINUTES USING A DIFFERENT METER AND OBTAINED READING OF 268 MG/DL. IT IS UNKNOWN IF ANOTHER METER WAS ASCENSIA OR NON-ASCENSIA METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9348608 ↗
• MalfunctionAug 16, 2019High Readings; High Readings

  THE CUSTOMER REPORTED THAT WITHIN 8 MINUTES, HE OBTAINED BLOOD GLUCOSE READINGS OF 141 MG/DL ON A NON-ASCENSIA METER AND 600 MG/DL ON A CONTOUR NEXT LINK 2.4 METER. THE CUSTOMER HAD NO SYMPTOMS OF HYPERGLYCEMIA. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8901217 ↗
• MalfunctionJul 17, 2019High Readings; High Readings

  THE CUSTOMER REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE READING OF 263 MG/DL ON HER CONTOUR NEXT LINK METER. THE CUSTOMER HAD NO SYMPTOMS OF HYPERGLYCEMIA. WITHIN 5 MINUTES, SHE PERFORMED A REPEAT TESTING ON A NON-ASCENSIA METER AND OBTAINED A READING OF 116 MG/DL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8799254 ↗
• InjuryJul 11, 2019High Readings; High Readings

  AT 8:23 A.M., THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 444 MG/DL ON HER CONTOUR NEXT LINK METER. SHE WAS PRESENTING WITH SYMPTOMS SUCH AS HEAVY SWEATING, LIGHTHEADEDNESS AND CONFUSION. SHE RECEIVED AN UNSPECIFIED AMOUNT OF INSULIN FROM HER INSULIN PUMP AND AFTER SOMETIME, SHE PASSED OUT. HER HUSBAND CALLED AN AMBULANCE. AFTER 10 MINUTES, THE PARAMEDICS ARRIVED. THEY RAN A TEST ON AN UNSPECIFIED BLOOD GLUCOSE METER AND OBTAINED A READING OF 32 MG/DL. THEY GAVE GLUCOSE SYRUP IN A TUBE TO THE CUSTOMER. THE CUSTOMER WAS TAKEN TO THE HOSPITAL AND SHE WAS HOSPITALIZED FOR 3 DAYS, WHERE SHE WAS TREATED WITH THE GLUCOSE SYRUP IN THE TUBE. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: Confusion/ Disorientation; Dizziness; Loss of consciousness; Sweating

  MAUDE report 8780716 ↗
• MalfunctionJul 1, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 33 MG/DL AND 253 MG/DL WITHIN 2 MINUTES ON A CONTOUR NEXT LINK 2.4 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8747703 ↗
• MalfunctionApr 5, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 331 MG/DL AND 69 MG/DL ON A CONTOUR NEXT LINK 2.4 METER AT 2:21 P.M. AND 2:29 P.M. RESPECTIVELY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. SINCE THE CUSTOMER USED ALL THE TEST STRIPS FROM THE AFFECTED VIAL, NO TEST STRIPS ARE EXPECTED TO BE RETURNED. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8486342 ↗
• MalfunctionSep 5, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 11:30 A.M., THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 83 MG/DL ON A CONTOUR NEXT LINK METER. WITHIN A MINUTE, THE CUSTOMER PERFORMED RETESTING ON TWO OTHER CONTOUR NEXT LINK METERS AND THE READINGS WERE 276 MG/DL AND 187 MG/DL. THE DIFFERENCES BETWEEN THE READINGS FALL IN THE "C" AND "D" ZONES OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER HAS BEEN ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. NEW TEST STRIPS, METER AND CONTROL SOLUTION WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7845595 ↗
• MalfunctionAug 31, 2018Unsealed Device Packaging; Unsealed Device Packaging

  THE CUSTOMER OPENED A BOX OF CONTOUR NEXT TEST STRIPS AND THE BOTTLE WAS ALREADY OPEN. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE STRIPS FOR INVESTIGATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7839448 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121190, K160430, K162336, K191286, K193407, K210687, K223293, K241787, 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-1739-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, 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-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-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-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-1259-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• 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-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-2211-2023 · May 19, 2023 · Open, Classified
  Contour next GEN Blood Glucose Monitoring System
• 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

…and 8 more.