V-Go Disposable Insulin Delivery V-Go 20 (REF 8560-9400-03)Recalls & reported problems

Summary

The FDA's MAUDE database contains 270 adverse event reports that list this exact device (DI 00385609400032), received between Oct 29, 2018 and May 27, 2025 — classified as 41 injuries, 229 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (115 reports).

5 other recalls cover devices cleared under the same FDA submission (K103825); 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 270 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THE START BUTTON OF THEIR V-GO 20 POPPED OFF (RELEASED). THE PATIENT REPORTED THAT THIS ISSUE OCCURRED TWICE WITH THE SAME DEVICE. IT WAS REPORTED THAT THE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087889 ↗
• MalfunctionSep 10, 2024Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEY WERE OUTSIDE SWEATING A LOT AND THE FIRST V-GO THEY APPLIED FELL OFF. THE PATIENT CLEANED THEIR SKIN WITH WATER AND ALCOHOL, WAITED FOR IT TO DRY, AND APPLIED A SECOND V-GO WHICH DID NOT APPLY TO THEIR SKIN. THE PATIENT CLEANED THEIR SKIN AGAIN AND A THIRD V-GO WAS APPLIED WHICH STUCK CORRECTLY. IT WAS REPORTED THAT THE TWO V-GO WERE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER, TO DATE, HAVE NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181046 ↗
• MalfunctionJul 11, 2024Premature Separation; Premature Separation

  THE PATIENT CALLED TO REPORT THAT V-GO 20 DEVICES FOR THE PAST 7 DAYS HAD ADHESIVE ISSUE AND FAILED TO STAY ON CLEAN SKIN. IT WAS REPORTED THAT DEVICES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER, TO DATE, HAVE NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721930 ↗
• MalfunctionJun 12, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PATIENT REPORTED THEIR V-GO 20 HAD A MALFUNCTION WHERE THE NEEDLE BUTTON POPPED BACK UP AND RETRACTED THE NEEDLE. THE PATIENT WAS UNABLE TO RESUME USE OF THAT V-GO DEVICE AND HAD TO SWITCH TO NEW DEVICE. THE PATIENT REPORTEDLY HAS ONE DEVICE AVAILABLE TO SEND BACK FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19520118 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THEIR BLOOD SUGAR GOT DOWN TO 52 ON (B)(6) 2024. SHE CALLED THE AMBULANCE BECAUSE SHE WAS NOT ABLE TO GET HER BLOOD SUGAR UP ON HER OWN BY CHEWING CANDY. THE PATIENT REPORTED THAT IT MIGHT HAVE BEEN USER ERROR (SHE MAY HAVE LOST COUNT OF HOW MANY CLICKED SHE PUSHED FOR BOLUS). THE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Confusion/ Disorientation; Hypoglycemia

  MAUDE report 19459318 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED FOR THE PAST YEAR THEY HAVE HAD THESE ISSUES MULTIPLE TIMES. YESTERDAY, WHILE ASLEEP, THE NEEDLE RELEASE BUTTON GOT PRESSED ON ITS OWN AND THE DEVICE CAME OFF AND INSULIN WAS RUNNING DOWN BUT SHE NEVER PRESSED THE BUTTON. SHE STATED IT ALSO HAS HAPPENED WHEN AWAKE AND SHE HIT THE DEVICE ON SOMETHING. NO ADDITIONAL SPECIFIC EVENT DATES OR NUMBER OF OCCURRENCES WERE PROVIDED. THE PATIENT STATED SHE NOTICED HER SUGAR GOING UP AND SHE THEN NOTICED THE RELEASE BUTTON WAS PRESSED. NO DEVICES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hyperglycemia; Lethargy; Malaise

  MAUDE report 19023849 ↗
• MalfunctionMar 28, 2024Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEY HAD ISSUES WITH A FEW OF THEIR V-GO 20 DEVICES IN WHICH THEY FELL OFF. NO SPECIFIC EVENT DATES OR NUMBER OF OCCURRENCES WAS REPORTED. IT WAS REPORTED THAT THE DEVICES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997312 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THEIR V-GO 20 DEVICE IS DISPENSING OVER 18 HOURS RATHER THAN 24 HOURS. IT WAS REPORTED THAT THE PATIENT WOKE UP IN THE MORNING WITH A BLOOD SUGAR OF 64 MG/DL. UPON FOLLOW-UP, THE PATIENT REPORTED THEY ALSO EXPERIENCED HYPERGLYCEMIA RANGING FROM 400-500 MG/DL. IT WAS REPORTED THAT THE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER, TO DATE, HAS NOT BEEN RECEIVED.

  Patient problems: Hyperglycemia

  MAUDE report 18989056 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THEIR V-GO SUDDENLY STOPPED DISPENSING INSULIN WHEN THEY CLICKED THE BOLUS BUTTON AND CAUSED HYPERGLYCEMIA. NO ADDITIONAL INFORMATION WAS PROVIDED AT INTAKE. IT WAS REPORTED THAT THE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER, TO DATE, HAS NOT BEEN RECEIVED.

  Patient problems: Hyperglycemia

  MAUDE report 18595829 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THE V-GO NEEDLE BUTTON WAS STUCK AND CAUSED HYPERGLYCEMIA. IT WAS REPORTED THAT A DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER, TO DATE, HAS NOT BEEN RECEIVED.

  Patient problems: Fatigue; Hyperglycemia

  MAUDE report 18440099 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THEIR SKIN UNDERNEATH THE ADHESIVE PAD IS ITCHING. ONCE REMOVED, THE PATIENT CAN SEE REDNESS AND RAISED SKIN. THE PATIENT REPORTED THAT HIS HEALTHCARE PRACTITIONER (HCP) PRESCRIBED SOME CREAM, BUT THE PATIENT COULD STILL SEE THE IRRITATED SKIN AFTER DAYS TO WEEKS. NO DEVICE WAS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 18428682 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA HAVING BLOOD GLUCOSE (BG) AT THE LEVEL BELOW 50 MG/DL ONCE WITH SYMPTOMS OF NERVOUSNESS, SHAKINESS, AND ANXIETY WHILE WEARING V-GO. IT WAS REPORTED THAT THE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Anxiety; Hypoglycemia; Shaking/Tremors

  MAUDE report 18143400 ↗
• MalfunctionOct 31, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEIR V-GO FELL OFF. THE PATIENT STATED THAT THE DEVICE FELL OFF WHEN THEY WERE SLEEPING. THE DEVICE WAS ON THE BACK OF THEIR RIGHT ARM. ADDITIONAL INFORMATION OBTAINED FROM THE PATIENT STATED THAT THE DEVICE FELL OFF AFTER TEN HOURS OF WEAR AND IT WAS THEIR FIRST DAY OF USING V-GO. THE PATIENT REPORTS FOLLOWING DIRECTIONS AS STATED IN THE V-GO MANUAL; SKIN CLEANED, WIPED WITH ALCOHOL PAD, DRIED, APPLIED TO SKIN, FINGERS RUBBED/PRESSED ALONG THE ADHESIVE EDGES. SHE DID NOT PRESS THE NEEDLE RELEASE BUTTON. WHEN THE DEVICE FELL OFF THE NEEDLE WAS EXPOSED. SHE DID NOT REAPPLY THE DEVICE AFTER IT FELL OFF. SHE DECIDED TO WAIT UNTIL SHE CONTACTED THE TRAINER TO MAKE SURE IT WAS APPLIED CORRECTLY. IT WAS REPORTED THAT THE DEVICE WAS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER, TO DATE, HAS NOT BE RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18040140 ↗
• MalfunctionOct 24, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT TWO MONTHS AGO THEY CHANGED V-GO SIZE WHEN GETTING REFILLS. THE PATIENT REPORTED THAT THE DEVICES FALL OFF EASILY WHEN SHE GOES OUTSIDE AND SWEATS A LITTLE BIT AND WHEN SHE SHOWERS. NO SPECIFIC EVENT DATES OR NUMBER OF OCCURRENCES WERE REPORTED. THE PATIENT REPORTED THAT NO DEVICES ARE AVAILABLE FOR RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995811 ↗
• MalfunctionOct 3, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT SHE HAS BEEN ON V-GO FOR SEVERAL YEARS WITH NO PROBLEMS, BUT THE RECENT BOX HAS HAD 4-5 V-GOS FALL OFF THE PATIENT'S BODY. IT WAS REPORTED THAT ONE DEVICE WAS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER, TO DATE, HAS NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860732 ↗
• MalfunctionAug 10, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEY HAD A V-GO 20 DEVICE FALL OFF IN THE SHOWER. THE PATIENT REPORTED THAT THEY CLEANED THE APPLICATION AREA ON THEIR ABDOMEN PRIOR TO APPLYING THE V-GO. THE PATIENT REPORTED PROBLEMS WITH THE DEVICE STAYING ATTACHED TO THEIR ABDOMEN. THE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498300 ↗
• MalfunctionJul 24, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THE NEEDLE BUTTON OF THEIR V-GO 20 RELEASED (POPPED OUT) DURING USE. THE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379578 ↗
• MalfunctionJul 24, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT 15 V-GO DEVICES FROM THEIR NEW BOX HAVE FALLEN OFF. THE EVENT DATES OF EACH OCCURRENCE WERE NOT PROVIDED. THE DEVICES ARE NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379574 ↗
• MalfunctionJun 30, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEIR V-GO 20 DEVICE KEEPS FALLING OFF. THERE ARE NO DEVICES AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17241757 ↗
• MalfunctionJun 30, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT TWO V-GO 20S FELL OFF DURING THE SAME DAY AND HE WAS ON HIS THIRD DEVICE. THE DEVICES ARE NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238543 ↗
• MalfunctionJun 6, 2023Premature Separation; Premature Separation

  A REGISTERED PHARMACIST REPORTED THAT THE PATIENT EXPERIENCED THEIR V-GO DEVICES FALL OFF FOUR TIMES. IT WAS REPORTED THAT THE PATIENT PREPS THEIR ARM WITH AN ALCOHOL WIPE AND LETS IT DRY BEFORE APPLYING. IT WAS REPORTED THAT A DEVICE SAMPLE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER, TO DATE HAS NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070821 ↗
• MalfunctionJun 6, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEY ARE LOSING THEIR V-GO'S. UPON CLARIFICATION THE PATIENT STATED THAT THE V-GO'S ARE FALLING OFF FIVE TO SIX TIMES. THE PATIENT ALTERNATES PLACEMENT ON THE LEFT AND RIGHT SIDE OF THE ABDOMEN. THERE IS NO DEVICE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. UPON FOLLOW-UP IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA.

  Patient problems: Hyperglycemia

  MAUDE report 17070621 ↗
• InjuryMay 15, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  A MANNKIND V-GO TRAINER ADVISED THAT THE FAMILY MEMBER OF A V-GO PATIENT CALLED TO REPORT THAT THE PATIENT'S V-GO WAS CHANGED LAST NIGHT WITH A NEW DEVICE AND THE PATIENT'S BLOOD SUGAR STARTED DROPPING. THE PATIENT WAS GIVEN JUICE BUT BLOOD SUGAR DID NOT IMPROVE. DEVICE WAS REMOVED FROM PATIENT AND BLOOD SUGAR DID NOT IMPROVE. 911 WAS CALLED AND PATIENT WAS TAKEN TO EMERGENCY ROOM. IT WAS REPORTED THAT THE PATIENT'S BLOOD SUGAR WAS AROUND THE 40'S. THE V-GO TRAINER DID SAY THEY NOTIFIED THE PATIENT'S HEALTHCARE PROFESSIONAL (HCP). IT WAS REPORTED THAT THE DEVICE WAS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER, TO DATE, THE DEVICE HAS NOT BEEN RETURNED.

  Patient problems: Hypoglycemia

  MAUDE report 16931258 ↗
• MalfunctionMay 12, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THEY APPLIED THEIR V-GO 20 ON (B)(6) 2023 AND ON THE MORNING OF (B)(6) 2023, THEY NOTICED THAT THE NEEDLE BUTTON POPPED UP/RELEASED. IT WAS REPORTED THAT THE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. TO DATE, THE DEVICE HAS NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16921503 ↗
• MalfunctionMay 8, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEY HAD TWO V-GO DEVICES FALL OFF PRIOR TO THE 24-HOUR WEAR PERIOD OVER THE WEEKEND OF (B)(6) 2023. IT WAS REPORTED THE ADHESIVE FAILED AND DISCONNECTED FROM THE BACK OF THE PATIENT'S ARM. IT WAS REPORTED THAT THE DEVICES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16888882 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103825. One submission often covers many models, so check the product and lot details in each record.

• Z-0197-2020 · Jul 3, 2019 · Terminated
  DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
• Z-0195-2020 · Jul 3, 2019 · Terminated
  DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03
• Z-0199-2020 · Jul 3, 2019 · Terminated
  DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02
• Z-0196-2020 · Jul 3, 2019 · Terminated
  DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02
• Z-0198-2020 · Jul 3, 2019 · Terminated
  DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03