PARADIGM® REAL-time MMT-522RNAS (UDI 00613994408907)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994408907), received between Jun 20, 2017 and Dec 1, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED THAT THE PUMP HAS A CRACK. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-522RNAS. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT PUMP HAS A DAMAGE AT RESERVOIR WINDOW, BETWEEN WINDOW AND ESC BUTTON. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER WILL DISCONTINUE TO USE THE PUMP. PRODUCT MMT-522RNAS WAS REQUESTED AND PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678380 ↗
• MalfunctionDec 6, 2018Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 110 MG/DL. THE CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS FLUSH. TROUBLESHOOTING WAS PERFORMED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8136636 ↗
• MalfunctionAug 6, 2018No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 126 MG/DL. CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING OUT DURING MANUAL PRIME PROCESS. CUSTOMER ADVISED DURING THE SEATING OF THE FORCE THE SENSOR DID NOT DETECT THE RESERVOIR. 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 7751028 ↗
• InjuryApr 20, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 450 MG/DL. CUSTOMER REPORTED THAT THEY HAD HIGH BLOOD GLUCOSE OF 302 MG/DL AND 313 MG/DL ON (B)(6) 2018. CUSTOMER CONTINUED HIGH BLOOD GLUCOSE WITH 261 MG/DL. CUSTOMER¿S CURRENT BLOOD GLUCOSE IS 261 MG/DL. CUSTOMER REPORTS THEY HAVE CONTACTED THEIR HEALTHCARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. CUSTOMER WAS OFF THE DEVICE PRIOR TO HOSPITALIZATION FOR LESS THAN 48 HOURS. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7448387 ↗
• MalfunctionJun 20, 2017Loose or Intermittent Connection

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP'S DRIVE SUPPORT CAP WAS LOOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 305 MG/DL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6654180 ↗

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-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• Z-1749-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
• 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-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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• 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