FreeStyle LibreLinkRecalls & reported problems across all models

We found 2 models of FreeStyle LibreLink by Abbott Diabetes Care Inc in the FDA's device registry (GUDID). Together they are named in 203 adverse event reports in the FDA's MAUDE database, received between Apr 9, 2019 and Sep 2, 2026 — classified as 200 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (165 reports).

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

Most reported FreeStyle LibreLink problems

FreeStyle LibreLink models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FreeStyle LibreLink 71732-01

  Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
  111 reports
• FreeStyle LibreLink 71733-01

  Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
  92 reports

Recent FreeStyle LibreLink adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50556703 ↗
• InjuryJul 5, 2026Application Program Problem

  AN UNSPECIFIED ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH A SAMSUNG PHONE 721B AND ANDROID OPERATING SYSTEM VERSION 2.13.1.11596. THE CUSTOMER REPORTED THAT DUE TO SIGNAL LOSS THEIR GLUCOSE LEVELS AND THEY WERE NOT ALERTED TO THE CHANGES IN THESE LEVELS. AS A RESULT, THE CUSTOMER LOST CONSCIOUSNESS. AFTER AN UNSPECIFIED AMOUNT OF TIME, THE CUSTOMER REGAINED CONSCIOUSNESS AND SELF-TREATED BY CONSUMING FOOD. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 25712207 ↗
• InjuryJun 2, 2026Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE 15 WITH IOS OPERATING SYSTEM VERSION 26.4.2. A CUSTOMER REPORTED RECEIVING A SIGNAL LOSS AND WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED FAINTING, SHAKING, DROWSINESS, AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS TREATED WITH GLUCOSE SHOT AND THREE BOTTLES OF GLUCOSE AID. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness; Shaking/Tremors; Sleepiness/Drowsiness/Somnolence

  MAUDE report 25368922 ↗
• InjuryJun 2, 2026Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE 15 WITH IOS OPERATING SYSTEM VERSION 26.4.2. A CUSTOMER REPORTED RECEIVING A SIGNAL LOSS AND WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED FAINTING, SHAKING, DROWSINESS, AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS TREATED WITH GLUCOSE SHOT AND THREE BOTTLES OF GLUCOSE AID. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness; Shaking/Tremors; Sleepiness/Drowsiness/Somnolence

  MAUDE report 25368899 ↗
• InjuryJun 2, 2026Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE 15 WITH IOS OPERATING SYSTEM VERSION 26.4.2. A CUSTOMER REPORTED RECEIVING A SIGNAL LOSS AND WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED FAINTING, SHAKING, DROWSINESS, AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER WAS TREATED WITH GLUCOSE SHOT AND THREE BOTTLES OF GLUCOSE AID. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness; Shaking/Tremors; Sleepiness/Drowsiness/Somnolence

  MAUDE report 25368898 ↗
• InjuryMay 26, 2026Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH SAMSUNG S24, ANDROID OPERATING SYSTEM AND VERSION 16. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS "NUMB HANDS, SHAKINESS OF HANDS" AND SELF-TREATED BY CONSUMING "JUICE, FOOD, SIRIPIRI GLUCOSE TABLETS, AND A CANDY". NO THIRD-PARTY TREATMENT WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Numbness; Shaking/Tremors

  MAUDE report 25284235 ↗
• InjuryMay 6, 2026Application Program Problem

  A SIGNAL LOSS ISSUE DUE TO AN INCOMPATIBLE OPERATING SYSTEM WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE USED WITH AN IPHONE (MODEL UNKNOWN) RUNNING IOS VERSION 2.13.1.9278. DUE TO THE INCOMPATIBLE CONFIGURATION, THE CUSTOMER DID NOT RECEIVE LOW GLUCOSE ALARMS. THE CUSTOMER REPORTED WEAKNESS AND SWEATING AND SELF-TREATED WITH GLUCOSE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Diaphoresis; Fatigue

  MAUDE report 25105301 ↗
• InjuryApr 23, 2026Application Program Problem

  AN UNSPECIFIED ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) APPLICATION IN USE ON AN UNKNOWN PHONE WITH AN UNKNOWN OPERATING SYSTEM AND VERSION. THE CUSTOMER INQUIRED ABOUT HOW TO INSTALL AND CONNECT TO THE LIBRELINK APP AND THE STEPS REQUIRED TO DO SO. THE CUSTOMER WAS UNABLE TO ACCESS THE FREESTYLE LIBRELINK APP DUE TO AN INCORRECT EMAIL AND PASSWORD COMBINATION. AS A RESULT, THE CUSTOMER WAS UNABLE TO MONITOR GLUCOSE READINGS. THE CUSTOMER EXPERIENCED DIZZINESS AND SELF-TREATED WITH A GLASS OF ORANGE JUICE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 24962123 ↗
• InjuryMar 31, 2026Application Program Problem

  AN INCOMPATIBLE APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH SAMSUNG A 53 6 B PHONE WITH ANDROID OPERATING SYSTEM AND VERSION 16. AS A RESULT, CUSTOMER WAS UNABLE TO MONITOR GLUCOSE READINGS AND NO GLUCOSE ALARMS. THE CUSTOMER EXPERIENCED ALMOST LOSING CONSCIOUSNESS, WAS UNABLE TO SELF-TREAT AND WAS ADMINISTERED A GLUCOSE INJECTION PROVIDED BY A THIRD-PARTY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 24749904 ↗
• InjuryMar 30, 2026Application Program Problem

  AN INCOMPATIBLE APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE 7 WITH ANDROID OPERATING SYSTEM AND VERSION 15.8.5. AS A RESULT, CUSTOMER WAS UNABLE TO MONITOR GLUCOSE READINGS AND NO GLUCOSE ALARMS. THE CUSTOMER EXPERIENCED CONVULSIONS AND SEIZURE. AFTER AN HOUR, THE CUSTOMER WAS ABLE TO SELF-TREAT BY DRINKING "WATER WITH SUGAR". NO THIRD-PARTY TREATMENT WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Convulsion/Seizure; Hypoglycemia

  MAUDE report 24713850 ↗
• InjuryFeb 18, 2026Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH AN HONOR MAGIC 7 PHONE WITH ANDROID OPERATING SYSTEM VERSION 15. THE LOW GLUCOSE ALARMS DID NOT SOUND, AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS, WAS UNABLE TO SELF-TREAT, AND RECEIVED SWEETENED WATER AND SWEETENED YOGURT PROVIDED BY A NON-HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 24379215 ↗
• InjuryFeb 12, 2026Device Alarm System

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT UNKNOWN PHONE, OPERATING SYSTEM AND VERSION. THE LOW GLUCOSE ALARMS DID NOT SOUND AND THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. ACCORDING TO THE CUSTOMER'S APPLICATION, THEIR BLOOD SUGAR WAS 50 MG/DL AND 52 MG/DL. THE CUSTOMER WAS THEN PROVIDED WITH POWDERED SUGAR AND A SUGARY DRINK (OASIS) BY A NON-HEALTHCARE PROFESSIONAL AS INITIAL TREATMENT. THE EMERGENCY SERVICES WAS CALLED AND UPON ARRIVAL, THE CUSTOMER'S BLOOD SUGAR WAS MEASURED ON A CAPILLARY TEST AND IT SHOWED 33 MG/DL. THE CUSTOMER'S BODY TEMPERATURE HAD DROPPED TO 34 DEGREES CELSIUS, SO THEY TAKE THEM TO A HOSPITAL. THE CUSTOMER WAS GIVEN AN UNSPECIFIED INTRAVENOUS DRIP BY A HEALTHCARE PROFESSIONAL AS TREATMENT FOR A DIAGNOSIS OF HYPOGLYCEMIA. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 24320159 ↗
• InjuryJan 9, 2026Application Program Problem

  AN APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH AN IPHONE 15 PRO WITH IOS OPERATING SYSTEM VERSION 26.1. THE CUSTOMER REPORTS THEY CANNOT SHARE DATA WITH THEIR CAREGIVER AND EXPERIENCED HYPOGLYCEMIA, A LOSS OF CONSCIOUSNESS AND REQUIRED MEDICAL ASSISTANCE; HOWEVER, NO TREATMENT DETAILS WERE PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 24030419 ↗
• InjuryDec 25, 2025Device Alarm System; Application Program Problem; Device Alarm System; Application Program Problem

  AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) APPLICATION IN USE WITH AN IPHONE (UNKNOWN MODEL) WITH IOS OPERATING SYSTEM, VERSION 18.6.2. THE CUSTOMER EXPERIENCED A SIGNAL LOSS AND WAS UNABLE TO OBTAIN READINGS AND RECEIVE LOW GLUCOSE ALARM. AS A RESULT, THE CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL AND EXPERIENCED SYMPTOMS SUCH AS BLIND VISION, SHAKING, AND NEEDING TO HOLD ONTO SOMETHING TO AVOID FALLING, AS WELL AS AN INABILITY TO HEAR ANYTHING. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND REQUIRED UNSPECIFIED THIRD-PARTY TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Blurred Vision; Shaking/Tremors

  MAUDE report 23891932 ↗
• InjuryNov 28, 2025Application Program Problem; Application Program Problem

  AN INCOMPATIBLE APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH SAMSUNG S921B WITH ANDROID OPERATING SYSTEM VERSION 16 AND APP VERSION 2.12.1.11476. AS A RESULT, CUSTOMER WAS UNABLE TO MONITOR GLUCOSE READINGS AND NO GLUCOSE ALARMS. THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS "VISCERALLY WHITE, TEMPERATURE 33 DEGREE CELSIUS", LOSS OF CONSCIOUSNESS, UNRESPONSIVE AND WAS UNABLE TO SELF-TREAT. AN AMBULANCE WAS CALLED AND RESPONDED, THE CUSTOMER WAS THEN PROVIDED WITH GLUCOSE INFUSION BY A HEALTHCARE PROFESSIONAL FOR A DIAGNOSIS OF HYPOGLYCEMIA THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 23672267 ↗

Other Abbott Diabetes Care Inc products

• FreeStyle Libre 314 models · 69,860 reports · 6 recalls
• FreeStyle Libre 3 Plus5 models · 52,808 reports · 2 recalls
• FreeStyle Libre 212 models · 30,420 reports · 2 recalls
• FreeStyle Libre 14 day5 models · 16,749 reports · 1 recall
• FreeStyle Lite9 models · 3,388 reports
• FreeStyle Libre 2 Plus4 models · 3,192 reports
• FreeStyle Freedom Lite5 models · 2,436 reports
• FreeStyle Libre7 models · 705 reports · 1 recall