MiniMed 530GRecalls & reported problems across all models
Medtronic Minimed, Inc. · 71 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one MiniMed 530G model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 48,745
- Deaths reported
- 191
- Injuries reported
- 14,855
- Recalls
- 1
We found 71 models of MiniMed 530G by Medtronic Minimed, Inc. in the FDA's device registry (GUDID). Together they are named in 48,745 adverse event reports in the FDA's MAUDE database, received between May 2, 2017 and Apr 29, 2026 — classified as 191 deaths, 14,855 injuries, 33,699 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (7,818 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
MiniMed 530G recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 13, 2026Open, Classified
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.
Z-1751-2026 · Root cause: Device Design · names 6 of these models · Recall details · FDA record ↗
Most reported MiniMed 530G problems
Device problems
- Device Difficult to Program or Calibrate7,818
- Patient Device Interaction Problem7,818
- Mechanical Problem7,778
- Obstruction of Flow6,202
- Device Displays Incorrect Message5,762
- Adverse Event Without Identified Device or Use Problem5,590
- Power Problem4,975
- No Display/Image4,638
Patient problems
- No Consequences Or Impact To Patient30,550
- Hyperglycemia14,420
- Hypoglycemia3,948
- Elevated Ketones/ Diabetic Ketoacidosis811
- No Known Impact Or Consequence To Patient351
- Death209
- Nausea198
- Blood Loss171
MiniMed 530G models
71 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MiniMed® 530G MMT-751NASArtificial pancreas device system, threshold suspend36 deaths7,479 reports
- MiniMed® 530G MMT-751NALArtificial pancreas device system, threshold suspend15 deaths3,405 reports
- MiniMed® 530G MMT-751LNASArtificial pancreas device system, threshold suspend1 recall7 deaths3,201 reports
- MiniMed® 530G MMT-551NASArtificial pancreas device system, threshold suspend5 deaths2,944 reports
- MiniMed® 530G MMT-751NABArtificial pancreas device system, threshold suspend11 deaths2,700 reports
- MiniMed® 530G MMT-751NAPArtificial pancreas device system, threshold suspend12 deaths2,637 reports
- MiniMed® 530G MMT-751LNASAutomated insulin dosing , threshold suspend1 recall2 deaths2,218 reports
- MiniMed® 530G MMT-751NASArtificial pancreas device system, threshold suspend16 deaths1,995 reports
- MiniMed® 530G MMT-751LNASArtificial pancreas device system, threshold suspend1 recall5 deaths1,923 reports
- MiniMed® 530G MMT-551NALArtificial pancreas device system, threshold suspend6 deaths1,938 reports
- MiniMed® 530G MMT-751NAHArtificial pancreas device system, threshold suspend5 deaths1,368 reports
- MiniMed® 530G MMT-751LNALArtificial pancreas device system, threshold suspend7 deaths1,267 reports
- MiniMed® 530G MMT-551NAPArtificial pancreas device system, threshold suspend5 deaths1,246 reports
- MiniMed® 530G MMT-551NABArtificial pancreas device system, threshold suspend3 deaths970 reports
- MiniMed® 530G MMT-751LNAPArtificial pancreas device system, threshold suspend5 deaths929 reports
- Medtronic MiniMed 530G MMT-751NASArtificial pancreas device system, threshold suspend3 deaths897 reports
- MiniMed® 530G MMT-751LNABArtificial pancreas device system, threshold suspend5 deaths853 reports
- MiniMed® 530G MMT-551LNASArtificial pancreas device system, threshold suspend4 deaths835 reports
- MiniMed® 530G MMT-751NALArtificial pancreas device system, threshold suspend2 deaths825 reports
- MiniMed® 530G MMT-551NASArtificial pancreas device system, threshold suspend3 deaths781 reports
- MiniMed® 530G MMT-751NABArtificial pancreas device system, threshold suspend4 deaths746 reports
- MiniMed® 530G MMT-551LNALArtificial pancreas device system, threshold suspend3 deaths708 reports
- MiniMed® 530G MMT-751LNAHArtificial pancreas device system, threshold suspend693 reports
- MiniMed® 530G MMT-551NAHArtificial pancreas device system, threshold suspend2 deaths671 reports
- MiniMed® 530G MMT-751NAPArtificial pancreas device system, threshold suspend1 death575 reports
- MiniMed® 530G MMT-551LNAPArtificial pancreas device system, threshold suspend499 reports
- MiniMed® 530G MMT-551NALArtificial pancreas device system, threshold suspend3 deaths478 reports
- MiniMed® 530G MMT-551LNABArtificial pancreas device system, threshold suspend370 reports
- MiniMed® 530G MMT-551LNAHArtificial pancreas device system, threshold suspend3 deaths351 reports
- MiniMed® 530G MMT-751NAHArtificial pancreas device system, threshold suspend2 deaths328 reports
- MiniMed® 530G MMT-551NAPArtificial pancreas device system, threshold suspend3 deaths325 reports
- MiniMed® 530G MMT-551NABArtificial pancreas device system, threshold suspend259 reports
- MiniMed® 530G MMT-551NASArtificial pancreas device system, threshold suspend1 death226 reports
- MiniMed® 530G MMT-551LNASArtificial pancreas device system, threshold suspend223 reports
- MiniMed® 530G MMT-751LNABArtificial pancreas device system, threshold suspend213 reports
- MiniMed® 530G MMT-751LNALArtificial pancreas device system, threshold suspend205 reports
- MiniMed® 530G MMT-551NAHArtificial pancreas device system, threshold suspend1 death163 reports
- MiniMed® 530G MMT-751LNAPArtificial pancreas device system, threshold suspend115 reports
- MiniMed® 530G MMT-751PNASArtificial pancreas device system, threshold suspend5 deaths114 reports
- MiniMed® 530G MMT-751NALArtificial pancreas device system, threshold suspend1 recall1 death58 reports
- MiniMed® 530G MMT-751NABArtificial pancreas device system, threshold suspend1 recall49 reports
- MiniMed® 530G MMT-551LNALArtificial pancreas device system, threshold suspend1 death97 reports
- MiniMed® 530G MMT-551PNASArtificial pancreas device system, threshold suspend2 deaths80 reports
- MiniMed® 530G MMT-751LNAHArtificial pancreas device system, threshold suspend80 reports
- MiniMed® 530G MMT-751NAPArtificial pancreas device system, threshold suspend1 recall29 reports
- MiniMed® 530G MMT-551LNAHArtificial pancreas device system, threshold suspend62 reports
- MiniMed® 530G MMT-551LNABArtificial pancreas device system, threshold suspend53 reports
- MiniMed® 530G MMT-551LNAPArtificial pancreas device system, threshold suspend53 reports
- MiniMed® 530G MMT-551NABArtificial pancreas device system, threshold suspend51 reports
- MiniMed® 530G MMT-751NAHArtificial pancreas device system, threshold suspend48 reports
- MiniMed® 530G MMT-751PNALArtificial pancreas device system, threshold suspend1 death46 reports
- MiniMed® 530G MMT-551NALArtificial pancreas device system, threshold suspend42 reports
- MiniMed® 530G MMT-751PNAPArtificial pancreas device system, threshold suspend35 reports
- MiniMed® 530G MMT-551NAHArtificial pancreas device system, threshold suspend35 reports
- MiniMed® 530G MMT-751PNAHArtificial pancreas device system, threshold suspend34 reports
- MiniMed® 530G MMT-551PNABArtificial pancreas device system, threshold suspend32 reports
- MiniMed® 530G MMT-551PNALArtificial pancreas device system, threshold suspend31 reports
- MiniMed® 530G MMT-551PNAPArtificial pancreas device system, threshold suspend31 reports
- MiniMed® 530G MMT-751PNABArtificial pancreas device system, threshold suspend26 reports
- MiniMed® 530G MMT-551NAPArtificial pancreas device system, threshold suspend23 reports
- MiniMed® 530G MMT-751RNASArtificial pancreas device system, threshold suspend1 death20 reports
- MiniMed® 530G MMT-551RNASArtificial pancreas device system, threshold suspend13 reports
- MiniMed® 530G MMT-551RNALArtificial pancreas device system, threshold suspend9 reports
- MiniMed® 530G MMT-751RNALArtificial pancreas device system, threshold suspend9 reports
- MiniMed® 530G MMT-751RNAPArtificial pancreas device system, threshold suspend7 reports
- MiniMed® 530G MMT-551PNAHArtificial pancreas device system, threshold suspend5 reports
- MiniMed® 530G MMT-751RNABArtificial pancreas device system, threshold suspend5 reports
- MiniMed® 530G MMT-751RNAHArtificial pancreas device system, threshold suspend3 reports
- MiniMed® 530G MMT-751PNALArtificial pancreas device system, threshold suspend2 reports
- MiniMed® 530G MMT-551RNAHArtificial pancreas device system, threshold suspend2 reports
- MiniMed® 530G MMT-551RNAPArtificial pancreas device system, threshold suspend2 reports
Recent MiniMed 530G adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 29, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA. THE CUSTOMER ALSO REPORTED AN UNSPECIFIED ISSUE. BLOOD GLUCOSE VALUE AT THE TIME OF THE EVENT WAS 45 MG/DL. THE EVENT INVOLVED PRODUCT(S) MMT-551NAP. TROUBLESHOOTING WAS PERFORMED. IT IS UNKNOWN WHETHER THE CUSTOMER WAS USING THE AUTO MODE/SMART GUARD FEATURE AT THE TIME OF THE EVENT. IT IS UNKNOWN WHETHER THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-551NAP WAS REQUESTED, AND THE DEVICE WAS RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 25026537 ↗MalfunctionMar 24, 2026Material Integrity Problem
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER HAD CRACK BETWEEN BATTERY COMPARTMENT AND RESERVOIR. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-751NAB. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE PUMP AND REVERT TO A BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. MMT-751NAB WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24672677 ↗MalfunctionJan 13, 2025Power Problem; Power Problem
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED BATTERY FAILED ALARM. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-751NAH. TROUBLESHOOTING WAS PERFORMED. CUSTOMER REPORTED THAT INSULIN PUMP STOPPED WORKING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-751NAH WAS RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21135556 ↗MalfunctionNov 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED DAMAGE (PHYSICAL OR COSMETIC). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-751NAB. TROUBLESHOOTING WAS PERFORMED. CUSTOMER REPORTED PUMP WAS DROPPED/BUMPED AND/OR PUMP HAS POSSIBLE PHYSICAL OR COSMETIC DAMAGE. CUSTOMER MENTIONED PUMP HAD A CRACK ON BATERRY AREA. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE. MMT-751NAB WAS REQUESTED AND THE DEVICE WAS RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20703524 ↗MalfunctionJun 21, 2024Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED MOTOR ERROR 3 TIMES. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND IT WAS RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19587420 ↗MalfunctionJun 6, 2024Break; Break
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER REPORTED INSULIN PUMP WAS DAMAGE (PHYSICAL OR COSMETIC). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-551NAP. TROUBLESHOOTING WAS PERFORMED IT WAS REPORTED LOCATION OF THE DAMAGE IS AT BATTERY COMPARTMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT MMT-551NAP WAS RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19474244 ↗MalfunctionApr 19, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER WAS NOT ABLE TO OPEN BATTERY CAP EVEN AFTER TRYING WITH COIN. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT MMT-751NAH. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS RETURNED FOR FAILURE ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19141844 ↗MalfunctionNov 29, 2023Battery Problem; Battery Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED THAT THE PUMP GAVE A LOW BATTERY ALARM A DAY AFTER NEW BATTERY WAS INSERTED. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS RETURNED FOR FAILURE ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18226494 ↗MalfunctionAug 24, 2023Failure to Cycle; Failure to Cycle
MEDTRONIC RECEIVED INFORMATION THAT THE INSULIN PUMP HAD AN A33 ALARM (COMPROMISED FORCE SENSOR SYSTEM). NO FURTHER DETAILS WERE PROVIDED. CUSTOMER HAS RECEIVED A NEW INSULIN PUMP AND NO REPLACEMENT NEEDED. NO DEVICE IS EXPECTED TO RETURN FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17608917 ↗MalfunctionAug 3, 2023Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED MOTOR ERRORS AND BUTTON ERRORS. THE CUSTOMER ALSO RECEIVED A NO DELIVERY ALARM. TROUBLESHOOTING WAS PERFORMED AND FOUND DRIVE CAP SUPPORT APPEARS NORMAL. IT WAS FOUND THAT THE CUSTOMER DIDN'T RECEIVE A BUTTON ERROR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND THE PUMP WAS RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17450052 ↗MalfunctionJul 11, 2023Break; Material Integrity Problem; Break; Material Integrity Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED BATTERY CAP WAS STRIPPED. TROUBLESHOOTING WAS PERFORMED AND FOUND THE DAMAGE ON THE BATTERY COMPARTMENT AND BATTERY CAP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND THE PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17296245 ↗MalfunctionJul 11, 2023Break; Break
INFORMATION RECEIVED BY MEDTRONIC INDICATED THE CUSTOMER REPORTED THE RESERVOIR CAP WAS BROKEN ON AN INSULIN PUMP AND THE RESERVOIR LIP WAS ALSO DAMAGED. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO THE PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE AND THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17295766 ↗MalfunctionJul 10, 2023Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED AN AA20 ALARM. THE PATIENT WAS ABLE TO COMPLETE THE REWIND PROCESS. NO TREATMENT WAS NECESSARY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17286304 ↗MalfunctionJun 16, 2023Break; Break
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP IS CRACKED NEAR THE BATTERY COMPARTMENT AND THE RESERVOIR LIP RING. NO TREATMENT WAS NECESSARY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS SUCCESSFULLY PERFORMED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE TO USE OF THE DEVICE, AND THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17140925 ↗MalfunctionJun 15, 2023Break; Break
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED DAMAGE TO THE THREADS IN THE BATTERY COMPARTMENT OF THE PUMP. TROUBLESHOOTING WAS PERFORMED AND IT WAS REPORTED THAT THE LOCATION OF THE DAMAGE IS AT THE BATTERY COMPARTMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER DISCONTINUED USING THE DEVICE AND THE DEVICE WAS RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17132663 ↗
Other Medtronic Minimed, Inc. products
- MiniMed 670G23 models · 141,169 reports · 4 recalls
- MiniMed 630G23 models · 65,972 reports · 6 recalls
- Paradigm REAL-Time Revel180 models · 49,838 reports · 2 recalls
- MiniMed670G2 models · 28,871 reports · 3 recalls
- MiniMed630G2 models · 6,656 reports · 5 recalls
- MiniMed Reservoir6 models · 4,545 reports
- PARADIGM REAL-time95 models · 2,862 reports · 1 recall
- Guardian Sensor (3)11 models · 2,726 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered, combining the brand names used for this product line.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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