V-Go Disposable Insulin Delivery V-Go 30 (REF 8560-9400-02)Recalls & reported problems

Summary

The FDA's MAUDE database contains 213 adverse event reports that list this exact device (DI 00385609400025), received between Dec 7, 2018 and Jun 1, 2026 — classified as 19 injuries, 194 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (94 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 213 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Premature Separation

  A PATIENT REPORTED HE HAD 3 DEVICES FALL OFF AFTER HE TOOK A SHOWER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347767 ↗
• MalfunctionMay 13, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT WITH THEIR RECENT BOX OF V-GO 30, THE NEEDLE POPS OUT PREMATURELY WHICH IS PAINFUL. THE PATIENT TRIED TO PUSH THE NEEDLE BACK IN AND THAT DID NOT WORK. IT WAS REPORTED THAT DEVICES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER, TO DATE, HAVE NOT BEEN RECEIVED.

  Patient problems: Pain

  MAUDE report 22009627 ↗
• InjuryFeb 10, 2025Premature Separation; Premature Separation

  A V-GO TRAINER CALLED TO REPORT THAT A PATIENT STATED THAT THEIR V-GO HAD FALLEN OFF AND THEY DID NOT HAVE ANY INSULIN FOR FOUR DAYS. THE PATIENT WAS THEN HOSPITALIZED WITH HIGH BLOOD SUGAR. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT STATED THAT THEY WERE HOSPITALIZED FROM (B)(6) 2025 TO (B)(6) 2025 DUE TO HIGH BLOOD SUGAR LEVELS/DIABETIC KETOACIDOSIS (DKA). THE PATIENT PUT HIS V-GO ON IN THE MORNING AROUND 9AM AND LEFT HIS HOME. HIS SUGARS STARTED GOING OUT OF RANGE AND IN ADDITION TO HIS HEART ISSUE, HE HAD TO GO TO THE HOSPITAL. THE V-GO WAS NOT DELIVERING INSULIN, AND THE PATIENT DID NOT HAVE ANY BACKUP INSULIN OUTSIDE THE HOUSE. PATIENT ALSO STATED THAT V-GO DOES NOT SUIT HIS VERY ACTIVE LIFESTYLE. NO DEVICES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 21349262 ↗
• MalfunctionJan 16, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT'S FAMILY MEMBER REPORTED THAT THE PATIENT ACCIDENTALLY POPPED THE NEEDLE BACK INTO THE V-GO SO THEY WASTED TO INSULIN (NEEDLE BUTTON RELEASED). IT WAS REPORTED THAT DEVICE SAMPLES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173145 ↗
• MalfunctionJan 16, 2025Premature Separation; Premature Separation

  THE PATIENT'S FAMILY MEMBER REPORTED THAT THE V-GO 30 DEVICE FELL OFF WHEN THE PATIENT WAS CLEANING. IT WAS REPORTED THAT DEVICE SAMPLES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172990 ↗
• MalfunctionNov 20, 2024Premature Separation; Premature Separation

  THE PATIENT'S NURSE REPORTED THAT FOR THE PAST MONTH, ALL THE PATIENT'S V-GO DEVICES HAVE BEEN FALLING OFF DAILY, AND SOMETIMES MULTIPLE TIMES PER DAY. NO SPECIFIC EVENT DATES WERE REPORTED. THE PATIENT'S NURSE STATED THAT THE PATIENT FOLLOWS PROPER SKIN PREPARATION PROCEDURES PRIOR TO APPLICATION. IT WAS REPORTED THAT NO DEVICES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737639 ↗
• MalfunctionNov 14, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PATIENT PLACED THEIR V-GO AT 9PM AND THE NEXT MORNING DURING LUNCH, THE PATIENT NOTICED THAT THE DEVICE POPPED (FELL) OFF. IT WAS REPORTED THAT THE DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683821 ↗
• MalfunctionAug 28, 2024Premature Separation; Premature Separation

  THE PATIENT'S SPOUSE REPORTED THAT THE PATIENT'S V-GO KEEPS FALLING OFF. THE SPECIFIC EVENT DATES AND NUMBER OF OCCURRENCES WERE NOT REPORTED. NO DEVICES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20088063 ↗
• MalfunctionAug 26, 2024Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THREE V-GO DEVICES HAVE FALLEN OFF. 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 20063636 ↗
• MalfunctionAug 21, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THE START BUTTON OF THEIR V-GO PUSHES OUT (RELEASES) DURING THE DAY WHILE THEY ARE STILL WEARING THE DEVICE. THE PATIENT REPORTED THAT THIS OCCURRED THREE TIMES WITH THE SAME BOX. SPECIFIC EVENT DATES WERE NOT PROVIDED. IT WAS REPORTED THAT A DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20023483 ↗
• MalfunctionJul 9, 2024Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT OVER THE LAST YEAR, THEY EXPERIENCED MULTIPLE V-GO DEVICES FALLING OFF. THE PATIENT REPORTED THAT THIS OCCURRED WITH V-GO FROM THREE DIFFERENT BOXES. THE SPECIFIC NUMBER OF OCCURRENCES AND EVENT DATES WERE NOT REPORTED. IT WAS REPORTED THAT DEVICES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702340 ↗
• InjuryJul 8, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE PATIENT REPORTED THAT THE V-GO DEVICE DELIVERED TOO MUCH INSULIN AND THE PATIENT'S BLOOD SUGAR DROPPED. THE PATIENT REPORTED THAT THEY COULDN'T FIGURE OUT WHY THEIR BLOOD SUGARS WERE SO VARIABLE AND TALKED TO THE PHARMACIST WHO SAID IT MIGHT BE THE V-GO MALFUNCTIONING. THE PATIENT REPORTED HIS BLOOD SUGAR WAS 70 AND THEN WENT DOWN TO 50 AND HE HAD TO TAKE HIS V-GO OFF TO KEEP IT FROM DROPPING MORE - HE DID NOT CLICK THE BOLUS BUTTON PRIOR TO THIS INCIDENCE. THE PATIENT STATED THERE ARE NO DEVICES AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Discomfort; Hypoglycemia

  MAUDE report 19690339 ↗
• InjuryJul 8, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE PATIENT REPORTED THAT THE V-GO DID NOT DELIVER ENOUGH INSULIN AND THEIR BLOOD SUGAR STAYED HIGH. IT WAS REPORTED THAT THE PATIENT COULDN'T FIGURE OUT WHY HIS BLOOD SUGARS WERE SO VARIABLE AND TALKED TO THE PHARMACIST WHO SAID IT MIGHT BE THE V-GO MALFUNCTIONING. HIS BLOOD SUGARS GOT UP TO 435 AND WOULD NOT GO DOWN EVEN WITH THE V-GO ON, AND WITH BOLUS CLICKS. HE DIDN'T HAVE ANY CHANGES IN DIET TO EXPLAIN THIS SPIKE IN BLOOD SUGAR. IT WAS REPORTED THAT THERE ARE NO DEVICES AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Discomfort; Hyperglycemia; Unspecified Eye / Vision Problem

  MAUDE report 19689809 ↗
• MalfunctionDec 19, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEIR V-GO DEVICE FELL OFF AFTER FOUR HOURS OF WEAR. THE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357576 ↗
• MalfunctionNov 2, 2023Premature Separation; Premature Separation

  THE PATIENT STATED THAT THE V-GO DEVICE FELL OFF IN THE SHOWER. THE PATIENT REPORTED SHE APPLIED THE DEVICE ON HER STOMACH AND SHOWERED LATER IN THE DAY. IT WAS REPORTED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18059313 ↗
• MalfunctionOct 9, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THE FIRST TIME SHE USED V-GO (ABOUT ONE MONTH AGO) THE DEVICE FELL OFF. THE PATIENT REPORTED THAT SHE HAS NOT HAD ANY PROBLEMS SINCE, AND BELIEVES THE DEVICE FELL OFF BECAUSE SHE WAS HOT AND SWEATY. IT WAS REPORTED THAT DEVICE SAMPLES WERE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, TO DATE, HAVE NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895483 ↗
• MalfunctionSep 28, 2023Premature Separation; Premature Separation

  THE WIFE OF A PATIENT USING V-GO REPORTED THAT TWO DEVICES FELL OFF. IT WAS SUSPECTED THAT THE DEVICES FELL OFF BECAUSE OF EXCESSIVE HAIR ON THE APPLICATION SITE. 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 17837317 ↗
• MalfunctionSep 20, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT STATED THAT THE NEEDLE KEEPS POPPING OUT OF HER BODY. THE PATIENT WEARS V-GO ON THEIR STOMACH AND STATED THAT THIS HAS OCCURRED FOUR TIMES. THE SPECIFIC EVENT DATES WERE NOT REPORTED. 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 17781843 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT HE GOT A SKIN INFECTION FROM THE ADHESIVE ON THE V-GO 30. IT WAS REPORTED THAT SAMPLES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Skin Infection; Skin Inflammation/ Irritation

  MAUDE report 17747700 ↗
• MalfunctionAug 17, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT IN TWO DAYS, FOUR V-GO 30 HAVE FALLEN OFF. ADDITIONALLY, THE PATIENT REPORTED A COUPLE DEVICES FELL OFF BEFORE THIS. THE PATIENT STATED THEY WERE UNSURE IF THIS ISSUE WAS DUE TO THE HEAT AND/OR PERSPIRATION. THE DEVICES ARE NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17567352 ↗
• MalfunctionAug 3, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEY HAVE HAD SEVEN V-GO 30'S FALL OFF. IT WAS REPORTED THAT THE APPLICATION SITE WAS PREPPED CORRECTLY. THE PATIENT WEARS V-GO ON THEIR ABDOMEN AND ROTATES EACH SIDE. THE DEVICES ARE NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION BECAUSE THEY WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17453692 ↗
• MalfunctionJul 24, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THREE OF THEIR V-GO 30S FELL OFF. IT WAS REPORTED THAT THE PATIENT PREPPED THE APPLICATION AREA WITH ALCOHOL WIPES AND LET THE SKIN AIR DRY. THE DEVICES WERE ON FOR 3-6 HOURS BEFORE FALLING OFF. THE DEVICES WERE REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378927 ↗
• MalfunctionJul 12, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED FOUR V-GO 30S THE NEEDLE BUTTON RELEASED PRIOR TO THE COMPLETION OF THE 24-HOUR WEAR PERIOD. THE PATIENT STATED THAT THEY WERE ALL FROM THE SAME ORDER. THE PATIENT WAS TRANSFERRED TO THE TRAINING LINE PER THEIR REQUEST TO ENSURE THAT THEY WERE USING THE PRODUCT CORRECTLY. THE DEVICES WERE REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306109 ↗
• MalfunctionJul 11, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THE V-GO 30 DEVICE FELL OFF THREE TIMES SINCE STARTING ON V-GO ON (B)(6)2023. THE MOST RECENT TIME WAS WHEN THE PATIENT WAS IN THE WATER. THERE ARE NO DEVICES AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298304 ↗
• MalfunctionJun 26, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEIR LAST BOX OF V-GO'S ARE COMPLETELY FALLING OFF AND HE HAD TO STOP USING THEM. THE PATIENT REPORTED THAT ONE OF THE DEVICES HAD THE NEEDLE STICK/SCRATCH HIM BEFORE FALLING OFF. THE PATIENT REPORTED NINE DEVICES FELL OFF, HOWEVER THE EXACT EVENT DATES FOR EACH WERE NOT REPORTED. THE PATIENT REPORTED GETTING AN AWFUL RASH ON ARM AND STOMACH AREA WHICH CRUSTED OVER. THE PATIENT REPORTED HE WILL GO SEE A DERMATOLOGIST. THE DEVICES WERE REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Needle Stick/Puncture; Rash; Skin Inflammation/ Irritation

  MAUDE report 17202717 ↗

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