Paradigm® REAL-Time Revel™ MMT-523LNAS (UDI 00643169479630)Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00643169479630), received between Jun 7, 2017 and Jan 28, 2020 — classified as 1 death, 13 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (9 reports).

14 other recalls cover devices cleared under the same FDA submission (P980022); 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

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF INCIDENT WAS 496 MG/DL. CUSTOMER STATED THE ANOTHER RELEVANT BLOOD GLUCOSE VALES 401 MG/DL, 406 MG/DL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. CUSTOMER WAS TREATED WITH THE BOLUS AND MANUAL INJECTION. NO PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9640310 ↗
• MalfunctionSep 12, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. ADVISED CUSTOMER'S MOTHER TO CALL BACK WHEN SHE HAD THE INSULIN PUMP AVAILABLE. THE DEVICE WILL NOT RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9001343 ↗
• MalfunctionJul 4, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8762383 ↗
• MalfunctionJun 20, 2019No Display/Image; Battery Problem; Power Problem; No Display/Image; Battery Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAVE TO CHANGE MULTIPLE BATTERIES TO GET THE INSULIN PUMP TO POWER ON. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8715573 ↗
• MalfunctionApr 30, 2019Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. CUSTOMER STATED THE PART OF THE RIDGE THAT HOLDS THE RESERVOIR HAS BROKEN OFF. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THE RESERVOIR STILL LOCKS INTO PLACE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8566656 ↗
• MalfunctionApr 22, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE RESERVOIR COMPARTMENT AREA WAS BROKEN. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE AND NOTICED THAT THE RESERVOIR OCCASIONALLY WILL WORK, IT WAS WAY LOOSE AND WILL CAUSE BLOOD GLUCOSE TO RISE. ADVISED THE PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8534948 ↗
• MalfunctionMar 22, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD HIPPED AND CRACKED AROUND RESERVOIR AREA O RING HAS COME OUT AND MENTIONED DOES NOT FEEL RESERVOIR IS SECURE. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8442556 ↗
• MalfunctionFeb 1, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATE THAT THEY WERE ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8295819 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THE THEY EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT INSULIN PUMP RECEIVE NO DELIVERY ALARM. CUSTOMER WAS REPORTING A PAST EVENT AND ALARM OCCURRED DURING MANUAL PRIME. CUSTOMER REPORTS EVENT WAS RESOLVED BY INFUSION SET CHANGE. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE VALUE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8269607 ↗
• InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE CUSTOMER¿S FAMILY REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED THE HYPOGLYCEMIA. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 50 MG/DL. THE CUSTOMER DOES NOT WANT TO TROUBLESHOT FOR THE HIGH AND THE LOW BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH THE GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 8136898 ↗
• MalfunctionOct 8, 2018Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD REJECTED NEW BATTERY AND NO DELIVERY ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTS WHEN THEY CHANGE THE BATTERY THE SCREEN WENT BLANK. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7943996 ↗
• InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL 54 MG/DL. CUSTOMER DID NOT TROUBLESHOOT THEIR LOW BLOOD GLUCOSE READING. CUSTOMER TREATED THEIR LOW BLOOD GLUCOSE WITH JUICE. THE PRODUCT WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7898912 ↗
• MalfunctionSep 11, 2018Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 277 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE DRIVE SUPPORT CAP IS PROTRUDING. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7867390 ↗
• MalfunctionJul 20, 2018Failure to Cycle; Leak/Splash; Device Displays Incorrect Message; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 210 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7705755 ↗
• MalfunctionJul 17, 2018Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER ALSO REPORTED THAT THE DEVICE WAS SQUIRTING OUT INSULIN DURING MANUAL PRIME PROCESS AND THE DRIVE SUPPORT CAP WAS FLUSH. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS NOT PROVIDED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7697098 ↗
• MalfunctionJul 16, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OF 455 MG/DL AS WELL AS RESERVOIR WON¿T STAY IN PLACE. CUSTOMER HAD MULTIPLE BLOOD GLUCOSE IS 447, 392, 123, 261, 109, 90 AND 107 MG/DL. THE CUSTOMER DID NOT EXPERIENCE ANY SYMPTOMS SUCH AS A RESULT OF HIGH BLOOD GLUCOSE. THE CUSTOMER TREATED WITH THE SYRINGES FOR HIGH BLOOD GLUCOSE. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVEL. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 7691943 ↗
• MalfunctionJul 11, 2018Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT THE INSULIN PUMP HAD ALARMED COMPROMISED FORCE SENSOR SYSTEM ALARM. BLOOD GLUCOSE WAS UNKNOWN AT TIME OF INCIDENT. TROUBLESHOOTING WAS COMPLETED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN PER HEALTHCARE PROVIDER'S INSTRUCTION. THE CUSTOMER WILL RECEIVE A REPLACEMENT INSULIN PUMP AND WILL RETURN THE ONE THEY CURRENTLY USE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7678340 ↗
• MalfunctionJul 3, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPRISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT DURING MANUAL PROCESS. CUSTOMER STATE THAT DRIVE SUPPORT CAP WAS PROTRUDED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7657541 ↗
• InjuryJun 22, 2018Infusion or Flow Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 535 MG/DL. CUSTOMER STATED THAT THEY TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. CUSTOMER STATES THAT HE ATTEMPTED TO PRIME THE INSULIN PUMP AND NOTICED THAT THE DEVICE WOULD REWIND BUT NOT PRIME PROPERLY. HE ATTEMPTED TO HIS PRIME HIS PUMP ON A SEPARATE OCCASION AND RECEIVED A NO DELIVERY ALARM. TROUBLESHOOTING WAS PERFORMED. DURING TROUBLESHOOTING, THE CUSTOMER CHANGED THE INFUSION SET AND RESERVOIR. CUSTOMER WAS STILL UNABLE TO PUSH INSULIN THROUGH THE TUBING WITH THE PLUNGER ROD. ADVISED CUSTOMER TO CHANGE THE ENTIRE INFUSION SET SYSTEM AS SOON AS POSSIBLE. ADVISED CUSTOMER TO RETURN THE INFUSION SETS AND RESERVOIRS FOR ANALYSIS. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. PRODUCT WILL NOT BE RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7628489 ↗
• MalfunctionJun 18, 2018Application Interface Becomes Non-Functional Or Program Exits Abnormally; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE ACT BUTTON WAS NOT RESPONSIVE. SCREENS ARE GRAY AND LETTERS ARE BLACK NOT ENOUGH CONTRAST WOULD BE EASIER TO SEE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE DEVICE WAS NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7608830 ↗
• MalfunctionJun 13, 2018Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND HAD PRIME REWIND. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 7595883 ↗
• InjuryApr 12, 2018Improper or Incorrect Procedure or Method; Incorrect Or Inadequate Test Results

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 25 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 355 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER HAD LOWS DUE TO OVER BOLUSING TO TREAT HIGHS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS COMPLETED. THE CUSTOMER HAD HIGHS ON (B)(6) 2018 OF 457, 429 MG/DL TO OVER 600 MG/DL WHICH THEY TREATED FOR WITH MANUAL INJECTIONS. THE CUSTOMER ALSO REPORTED HIGHS OF 430 TO 523 ON THE DAY OF THE CALL. THE CUSTOMER EXPERIENCED HIGH SYMPTOMS SUCH AS DRY MOUTH AND THEY TREATED WITH MANUAL INJECTIONS AND THE PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 7424647 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE WAS 25 MG/DL ON UNKNOWN DATE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL 25 MG/DL, 430 MG/DL AT TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE 523 MG/DL, 355 MG/DL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL OVER 600 MG/DL, 457 MG/DL AND 429 MG/DL. THE CUSTOMER HAD SYMPTOMS SUCH AS MOUTH DRY. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION AND BOLUS. THE CUSTOMER REPORTED THAT THEY HAD ISSUES WITH THE INSULIN PUMP. THE CUSTOMER WAS ADVISED THE PUMP IS DESIGNED TO TRIGGER AN ALARM IF IT DETECTS A BLOCKAGE PREVENTING THE FLOW OF INSULIN. THE CUSTOMER WAS ADVISED IF THEY HAVE CONCERNS THEIR PUMP MAY NOT HAVE DETECTED AN OCCLUSION WE CAN TEST THIS ALARM USING A TUBING CLAMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7410534 ↗
• MalfunctionMar 22, 2018Device Displays Incorrect Message; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. CUSTOMER WAS REWINDING PUMP AND DURING THE PRIME IT WAS SPRAYING INSULIN. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7362829 ↗
• MalfunctionFeb 2, 2018Device Operates Differently Than Expected

  THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE CUSTOMER HAD HIGH BLOOD GLUCOSE. CUSTOMER DID NOT BELIEVE HER PUMP WAS GIVING HER THE CURRENT AMOUNT OF INSULIN. CUSTOMER STATED THAT, AFTER SHE DOES A BOLUS HER BLOOD GLUCOSE IS STILL RISING. THE CURRENT BLOOD GLUCOSE WAS 252 MG/DL. CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH BOLUS. BASED ON CUSTOMER REPORT PROCEEDING IN TROUBLESHOOTING PER CUSTOMER ALLEGING POSSIBLE PUMP UNDER DELIVERY. THE DRIVE SUPPORT CAP APPEARS NORMAL. RUN MANUAL PRIME AND FILL TUBING WITH CURRENT SET AND INSULIN EXITED AT THE QUICK RELEASE SET. CUSTOMER ADVISED TO CHANGE ENTIRE SET, RESERVOIR AND INSULIN AND TREAT PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7239228 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P980022. One submission often covers many models, so check the product and lot details in each record.

• Z-1749-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
• Z-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• Z-1256-2025 · Jan 31, 2025 · Open, Classified
  Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-2442-2015 · Jul 22, 2015 · Terminated
  Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with d
• Z-2179-2014 · Jul 21, 2014 · Terminated
  Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combinatio
• Z-2544-2014 · Mar 13, 2014 · Terminated
  Medtronic 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