MiniMed® 530G MMT-751LNAP (UDI 00643169933217)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-751LNAP PRDGM V3.0 PL EN PR LN · Class 3
All models of MiniMed 530G (71)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This MiniMed 530G insulin pump, used in a threshold-suspend diabetes system, has 115 adverse event reports on file. Many describe error alarms, buttons that stick or do not respond, and difficulty rewinding the pump, and some describe a blank display or a grinding motor. The reports include no deaths and 27 injuries, and listed patient problems include high blood sugar. 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
- 115
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 00643169933217), received between Jan 5, 2018 and Aug 7, 2020 — classified as 27 injuries, 88 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (27 reports).
2 other recalls cover devices cleared under the same FDA submission (P120010); 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 18, 2026.
Most reported problems
Device problems
- Device Difficult to Program or Calibrate27
- Obstruction of Flow25
- Patient Device Interaction Problem24
- Mechanical Problem22
- Power Problem16
- Adverse Event Without Identified Device or Use Problem13
- Battery Problem7
- No Display/Image6
Patient problems
- No Consequences Or Impact To Patient82
- Hyperglycemia29
- Hypoglycemia4
Recent adverse event reports
The 25 most recent of 115 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2020Premature Discharge of Battery; Premature Discharge of Battery
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. THE INSULIN PUMP ERROR OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10377735 ↗MalfunctionAug 5, 2020No Display/Image; No Display/Image
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. CUSTOMER STATED THE BATTERY WAS CHANGED, BUT THE ISSUE WAS NOT RESOLVED. CUSTOMER STATED THE DISPLAY WAS NOT BLANK LESS THAN 30 SECONDS AND DID NOT RETURN. CUSTOMER STATED THE CONTACT ON THE BATTERY CAP WAS NEITHER MISSING NOR DAMAGE. CUSTOMER STATED BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THE SPRING WAS NEITHER DAMAGED NOR CORRODED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10366520 ↗MalfunctionJul 24, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF INSULIN PUMP WERE HARD TO PUSH. THE CUSTOMER STATED THAT MOST OF THE BUTTONS WERE UNRESPONSIVE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10318964 ↗MalfunctionApr 8, 2020Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THAT THE INSULIN PUMP WAS GRINDING WHILE REWOUND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9937852 ↗MalfunctionMar 30, 2020Premature Discharge of Battery; Mechanical Problem; Premature Discharge of Battery; Mechanical Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD AN INSULIN PUMP ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE 130 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATES THE INSULIN PUMP ERROR WAS CLEARED HOWEVER THERE ARE CONTINUOUS ISSUES WHEN TRYING TO REWIND THE PUMP. TROUBLESHOOTING WAS PERFORMED HOWEVER ISSUE WAS NOT RESOLVED. THE INSULIN PUMP IS RETURNING FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9896703 ↗MalfunctionMar 19, 2020Premature Discharge of Battery; Premature Discharge of Battery
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND NOT ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED THAT THE REWIND PROCESS HAD NOT BEEN COMPLETED AT THE FIRST TIME BECAUSE IT REQUIRED TO REWIND MANY TIMES AND IT WORK AT THE THIRD OR FOURTH ATTEMPT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9852190 ↗MalfunctionJan 24, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTON WERE HARD TO PRESS. CUSTOMER STATED THEY HAD TO PRESS WITH FINGERNAILS AND HAD WORN BUTTONS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9626836 ↗MalfunctionJan 21, 2020Device Difficult to Program or Calibrate; Battery Problem; Device Difficult to Program or Calibrate; Battery Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE STICKING. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE BUTTONS WERE PRESSED MORE THAN 3 TIMES. THE ACT BUTTON AND BOLUS BUTTONS WERE THE ONES THAT THEY USED THE MOST. CUSTOMER STATED THAT THEY GOT LOW BATTERY ALERT AND BAD BATTERY ALERT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9614313 ↗InjuryJan 15, 2020Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL. CUSTOMER TREATED WITH MANUAL BOLUSES USING NEEDLES. CUSTOMER HAD USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER DOES NOT USE AUTO MODE. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL. CUSTOMER ALLEGING POSSIBLE INSULIN PUMP UNDER DELIVERY BECAUSE SHE TRIED TO DELIVER BOLUS AND IT¿S NOT LOWERING HER BLOOD GLUCOSE THAT HE STILL NEEDS TO DO MANUAL NEEDLES. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS FLUSH. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9590921 ↗InjuryDec 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. BLOOD GLUCOSE LEVEL OF THE CUSTOMER WAS 500 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS TREATED WITH MANUAL INJECTIONS AND THEY DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9530393 ↗MalfunctionDec 24, 2019Computer Software Problem; Insufficient Flow or Under Infusion; Patient Device Interaction Problem; Computer Software Problem; Insufficient Flow or Under Infusion; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT BOLUS DELIVERED SLOWER THAN EXPECTED. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 231 MG/DL. THE INSULIN PUMP HAD SCRATCHES ON SCREEN AND SOMETIMES FELL OFF BECAUSE SHE DIDN'T HAVE CLIP TO HOLD. THE INSULIN PUMP DID NOT DELIVER INSULIN PROPERLY. THE CUSTOMER WAS ADVISED TO PROGRAM A 0.75 UNIT BOLUS. BOLUS EXCEEDED THE EXPECTED TIME TO DELIVER BOLUS AMOUNT. THE CUSTOMER WAS ADVISED TO MONITOR INSULIN PUMP FOR THEIR BLOOD GLUCOSE VALUES. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9516268 ↗MalfunctionNov 22, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR AND BUTTON ALWAYS RESPOND WHEN FIRST PRESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP HAD HAIRLINE FRACTURE ON CASING AND UNEXPLAINED NO DELIVERY ALERTS. CUSTOMER STATED INSULIN PUMP SLOWER DURING REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9360537 ↗MalfunctionNov 16, 2019Mechanical Problem; Mechanical Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR POSITION ENCODER ERROR ALARM AND MOTOR ERROR ALARM IN HISTORY. CUSTOMER¿S BLOOD GLUCOSE WAS 112 MG/DL. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. TROUBLESHOOTING WAS PERFORMED FOR MOTOR ERROR ALARM. CUSTOMER WAS ADVISED CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED, TO DISCONTINUE USE OF THE INSULIN PUMP AND REFER TO BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9332645 ↗MalfunctionNov 12, 2019Device Alarm System; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Device Alarm System; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP WAS NOT ALARMING WHEN CUSTOMER WAS LOW AND DID NOT MAKE A SOUND. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP HAD DIMINISHED BATTERY LIFE, HAD INACCURATE READING FROM CONTINUOUS GLUCOSE MONITORING. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9313561 ↗MalfunctionNov 12, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT WHERE THEY INSERT THE BATTERY IN; IT WON'T UNSCREW AND WAS BROKEN AROUND THE RESERVOIR COMPARTMENT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 199 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED DAMAGE TO THE RESERVOIR LIP RING AND THE BATTERY COMPARTMENT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9313501 ↗MalfunctionNov 8, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9296964 ↗MalfunctionOct 18, 2019Failure to Cycle; Device Difficult to Program or Calibrate; Priming Problem; Failure to Cycle; Device Difficult to Program or Calibrate; Priming Problem
CUSTOMER REPORTED VIA PHONE CALL THAT BUTTONS WERE HARDER TO PRESS AND INSULIN PUMP WAS SQUIRTING OUT INSULIN DURING PRIMING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9206186 ↗MalfunctionOct 17, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow
CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS ON INSULIN PUMP WERE UNRESPONSIVE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9201019 ↗MalfunctionSep 24, 2019Obstruction of Flow; Material Integrity Problem; Obstruction of Flow; Material Integrity Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE AND THEY RECEIVED NO DELIVERY ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 597 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THE BATTERY CAP WAS CRUMBLED AND WORN. CUSTOMER STATED THEY HAD TRIED ALL REMEDIES. CUSTOMER DID NOT FEEL SAFE IN USING THE INSULIN PUMP DUE TO THE NO DELIVERY ALERTS CAUSING HIGHS. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9108585 ↗MalfunctionSep 12, 2019Mechanical Problem; Obstruction of Flow; Detachment of Device or Device Component; Mechanical Problem; Obstruction of Flow; Detachment of Device or Device Component
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 162 MG/DL AND 353 MG/DL. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS FLUSH. ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9003145 ↗MalfunctionAug 22, 2019Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE NON-RESPONSIVE. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT THE REJECTED BATTERY MULTIPLE TIMES AND PIECES BROKE OFF FROM DROPPING INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8920853 ↗MalfunctionAug 21, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT SCRATCHES AND RAINBOW EFFECT ON SCREEN MAKING HARDER TO READ. THE BLOOD GLUCOSE WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR THE ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8914662 ↗MalfunctionAug 16, 2019Priming Problem; Priming Problem
CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN SHOOTING OUT AND BEING WASTED DURING PRIMING. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8900147 ↗MalfunctionAug 9, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MOTOR ERROR AND BUTTONS WERE HARD TO PRESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP REWIND TAKES LONGER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8878416 ↗MalfunctionAug 7, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem
CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP¿S BUTTONS WERE LITTLE MORE DIFFICULT TO PRESS. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMERS STATED THAT CUSTOMER WAS CHANGING BATTERIES OUT ON EVERY SINGLE DAY, BATTERY LIFE HAS DIMINISHED SEVERELY AS WELL AS INSULIN PUMP REJECTED NEW BATTERIES. CUSTOMER ALSO STATED THAT INSULIN PUMP WAS SLOWER AND LOUDER TO REWIND, RECEIVED RANDOM NO DELIVERY ALARMS EVERY COUPLE OF MONTHS. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8868507 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P120010. One submission often covers many models, so check the product and lot details in each record.
- Z-1751-2026 · Feb 13, 2026 · Open, ClassifiedMiniMed 530G Insulin Pump (MMT-551, MMT-751)
- Z-2544-2014 · Mar 13, 2014 · TerminatedMedtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K
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 18, 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