V-Go Disposable Insulin Delivery V-Go 20 (REF 8560-9600-03)Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00385609600036), received between Sep 27, 2018 and May 17, 2023 — classified as 6 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (27 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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEIR V-GO 20 DEVICE DID NOT HOLD WHILE SHOWERING. 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 16946363 ↗
• MalfunctionMay 1, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THEY WERE DRIVING, AND THE NEEDLE BUTTON OF THEIR V-GO 20 RELEASED. THE PATIENT COULD NOT REMEMBER THE DATE IN WHICH THE EVENT OCCURRED. IT WAS REPORTED THAT THE DEVICE IS 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 16843494 ↗
• MalfunctionSep 6, 2022Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT HE HAD TROUBLE WITH 3 V-GO 20 DEVICES LATELY WHERE THE V-GO DEVICES HAVE COME OFF OF THE BACK OF HIS ARM AND ON THE ABDOMEN NO MORE THAN 5 HOURS INTO USE. THE PATIENT CONFIRMED THAT HE USES AN ALCOHOL SWAB TO CLEAN THE INFUSION SITE AND HE ALSO SHAVES PRIOR TO APPLYING THE V-GO. THE PATIENT MENTIONED THAT WHEN THE V-GO DEVICES COME OFF, THERE IS LITTLE TO NO ADHESIVE THAT CAN BE FELT. THE PATIENT STATED THAT HE HAD THIS SAME PROBLEM PREVIOUSLY OFF AND ON AND ESTIMATES THAT IT PREVIOUSLY HAPPENED WITH 1 V-GO OUT OF EACH BOX SINCE STARTING BACK IN (B)(6) 2017. THE PATIENT ALSO MENTIONED THAT HE HAS TROUBLE WHERE HE SWEATS. NO DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15364468 ↗
• MalfunctionJul 25, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT CALLED TO REPORT THAT OVER THE PAST MONTH THEY HAVE HAD APPROXIMATELY 7 V-GO 20 DEVICES WHERE THE NEEDLE BUTTON WILL RELEASE ON ITS OWN, WITH THE MOST RECENT ONE HAPPENING THIS MORNING. ON A FEW OCCASIONS SHE HAS BEEN ABLE TO PRESS THE NEEDLE BUTTON BACK IN. THE PATIENT CONFIRMED THAT THE V-GO DEVICES HAVE NOT BEEN BUMPED IN ANY WAY. THE PATIENT STATED THAT THEY FEEL AS IF IT IS SCRATCHING THEM WHEN THE NEEDLE BUTTON RELEASES. NONE OF THE V-GO 20 IN QUESTION ARE NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15096109 ↗
• MalfunctionJul 19, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A PATIENT REPORTED THAT OVER THE PAST 3 OR 4 DAYS, THEY HAVE HAD THREE V-GO 20 DEVICES WHERE THE NEEDLE BUTTON POPPED OUT WITHIN 4 MINUTES OF INITIAL NEEDLE INSERTION. THE PATIENT CONFIRMED THAT THEY PRESS ON THE RAISED CIRCULAR BUMP OF THE NEEDLE BUTTON DURING INITIAL NEEDLE INSERTION. 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 15051567 ↗
• MalfunctionJun 24, 2022Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THE LAST 3 V-GO 20 DEVICES HAVE FALLEN OFF OF HER STOMACH AND IT DOES NOT SEEM LIKE THE ADHESIVE HAS ENOUGH GLUE. THE PATIENT STATED THAT WITH THE PREVIOUS BATCH, THERE WAS TOO MUCH GLUE AND THE V-GO 20 DEVICES WERE STICKING TOO TIGHTLY CAUSING IT TO HURT WHEN PULLING THEM OFF. THE PATIENT CONFIRMED THAT SHE USES AN ALCOHOL SWAB TO CLEAN THE INFUSION SITE PRIOR TO APPLYING THE V-GO. THE PATIENT STATED THAT THE LAST V-GO FELL ON THE FLOOR WHILE SHE WAS GETTING UP WHICH WAS ALMOST AT 24 HOURS OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14806043 ↗
• MalfunctionMay 26, 2022Premature Separation; Premature Separation

  THE PATIENT'S DAUGHTER REPORTED THAT HER MOM HAS HAD 5 V-GO DEVICES WITHIN THE LAST WEEK THAT HAVE FALLEN OFF PATIENT BODY. THE PATIENT DAUGHTER MENTIONED THAT THEY STAYED ON HER MOM FOR APPROXIMATELY 1 TO 4 HOURS AND THEN FELL OFF. THE PATIENT IS WEARING THE V-GO ON THE BACKSIDE OF HER ARM. THE PATIENT DAUGHTER CONFIRMED THAT HER MOM WAS PREPARING THE INFUSION SITE PROPERLY BY CLEANING THE AREA WITH A ALCOHOL SWAB AND LETTING THE AREA DRY. THE PATIENT DAUGHTER STATED THAT HER MOM PLACED BACK ON 2 V-GO DEVICES AFTER IT HAD FALLEN OFF AND IT HURT PATIENT.

  Patient problems: Pain

  MAUDE report 14516146 ↗
• MalfunctionApr 21, 2022Premature Separation; Premature Separation

  THE PATIENT STATED THAT THE ADHESIVE IS NOT STICKING WELL AND CAME OFF ABOUT HALFWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14171634 ↗
• MalfunctionOct 27, 2021Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT V-GO FELL OFF. THE PATIENT STATED THAT THIS HAPPENED WITHIN THE LAST MONTH WITH 6 V-GO DEVICES. THE PATIENT STATED THAT TODAY V-GO FELL OFF IMMEDIATELY, AND IN THE OTHER OCCASIONS V-GO FELL OF AFTER BEFORE 4-6 HOURS. THE PATIENT WEARS THE V-GO ON HER ARMS AND CHANGES SITES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12703579 ↗
• MalfunctionAug 12, 2021Premature Separation; Premature Separation

  THE PATIENT REPORTED THE LOSS OF 7 V-GO 20 DEVICES BECAUSE THE ADHESIVE PAD DID NOT STAY ATTACHED TO THE BODY. PATIENT REPORTED THAT SHE PROPERLY PREPARED THE AREA WHERE THE V-GO DEVICES WERE APPLIED (ARM, ABDOMEN, THIGH) AND DESPITE ENSURING THE ADHESIVE PAD WAS SECURE THE V-GO DEVICES BECAME DETACHED WITHIN A TIME PERIOD OF ABOUT 12 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315809 ↗
• MalfunctionAug 10, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED A V-GO DEVICE TODAY WHERE THE NEEDLE BUTTON PARTIALLY RETRACTED THE NEEDLE FROM HER SKIN CAUSING FOR IT TO SCRATCH HER WHEN SHE MOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303076 ↗
• MalfunctionAug 5, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ADVERSE EVENT ASSESSOR(AEA) STATED THAT THE PATIENT REPORTED THE AEA THAT THE NEEDLE BUTTON DID NOT STAY LOCKED. THE PATIENT REPORTED THAT THE EVENT HAPPENED ON (B)(6) 2021 AT 8:00AM THE PATIENT LOCKED THE NEEDLE BUTTON AND BETWEEN 2:00-2:30PM, IT WAS UNLOCKED. THE AEA INDICATED THAT THE PATIENT MENTIONED THAT SHE DID HEAR THE CLICK, PRESSED THE NEEDLE BUTTON ON THE ROUNDED TIP. THE PATIENT MENTIONED THAT SHE WAS NOT GETTING THE INSULIN HER BODY NEEDED. THE PATIENT STATED THAT SHE DID NOT CLICK THE NEEDLE RELEASE BUTTON, BY ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12283478 ↗
• MalfunctionJul 22, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT 7 OF HER V-GO DEVICES THE NEEDLE BUTTON WOULD NOT STAY LOCKED DOWN. THE PATIENT CONTINUED SAYING ACROSS THE 7 DEVICES PATIENT ONLY WORE THEM FOR A FEW HOURS BEFORE THE NEEDLE BUTTONS POPPED UP. THE PATIENT STATED SHE DID NOT ACCIDENTALLY ACTIVATE THE NEEDLE RELEASE BUTTON ON ANY OF THE 7 DEVICES. THE PATIENT LET ME KNOW SHE WEARS V-GO ON HER ABDOMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12210276 ↗
• MalfunctionJul 19, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THE NEEDLE BUTTON RELEASED ON ITS OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12193332 ↗
• MalfunctionJul 7, 2021Premature Separation; Premature Separation

  THE PATIENT REPORTED THE NEEDLE CAME OUT OF HIS BODY AND THE DEVICE FELL OFF HIS ABDOMEN AFTER WEARING IT FOR 11 HOURS. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS. THE PATIENT STATED THERE WAS NO INCREASED MOVEMENT OR INTERFERENCE FROM HIS CLOTHING WHEN THE V-GO FELL OFF. THE PATIENT PREPARES THE ABDOMEN FOR A V-GO WITH AN ALCOHOL WIPE AND LETS IT DRY BEFORE APPLYING A V-GO. THE PATIENT TRIES TO AVOID AREAS THAT HAVE EXCESS SKIN, MUSCLE, BONE, SCARS, AND REMOVES HAIR FROM THE AREA WERE PATIENT APPLIES THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127701 ↗
• MalfunctionJun 23, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT WITH 4 V-GO'S, THE NEEDLE BUTTON POPPED OUT HOURS INTO USE. THE PATIENT STATED THAT WHEN SHE WAS BENDING OVER, THE NEEDLE BUTTON POPPED OUT AND SHE COULD FEEL THE NEEDLE STABBING HER. THE PATIENT MENTIONED THAT SHE PRESSES ON THE MIDDLE OF THE NEEDLE BUTTON DURING INITIAL NEEDLE INSERTION. THE PATIENT DISPOSED OF THE WORN V-GO'S .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051945 ↗
• MalfunctionJun 23, 2021Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THE V-GO FELL OFF WITH IT APPLIED TO HER ABDOMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051922 ↗
• MalfunctionJun 23, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THE NEEDLE BUTTON POPPED OUT MIDWAY INTO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050009 ↗
• MalfunctionJun 22, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT 3 DEVICES WHERE THE NEEDLE POPPED BACK UP WHILE HE WAS GIVING HIMSELF BOLUS DELIVERY CLICKS. THE PATIENT DOES NOT REMEMBER THE SPECIFIC DATES BUT THE LAST TIME IT OCCURRED WAS (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12043050 ↗
• MalfunctionJun 16, 2021Activation, Positioning or Separation Problem; Premature Separation; Activation, Positioning or Separation Problem; Premature Separation

  THE PATIENT REPORTED THAT THE NEEDLE BUTTON ACCIDENTLY RELEASED PRIOR TO THE COMPLETION OF THE 24-HOUR PERIO AND THAT THE V-GO DEVICE FELL OFF AFTER ABOUT TWELVE HOURS OF BEING APPLIED. PATIENT CONFIRMED THAT THE APPLICATION SITE WAS PROPERLY PREPARED AND THERE WAS NO INTERFERENCE WITH CLOTHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12010033 ↗
• MalfunctionJun 15, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PATIENT REPORTED THAT THE NEEDLE BUTTON POPPED OUT BEFORE 24 HOURS. PATIENT STATED THAT ON (B)(6) 2021 WHILE SITING AT HER DESK THE NEEDLE BUTTON POPPED OUT. PATIENT STATED THAT ON (B)(6) 2021 PATIENT WAS SITTING ON THE BED AND THE NEEDLE BUTTON POPPED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11999834 ↗
• MalfunctionJun 1, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PATIENT REPORTED EXPERIENCING THE NEEDLE BUTTON POPPING OUT BEFORE 24 HOURS WITH 4 V-GO'S OVER THE PAST WEEK. PATIENT STATED THAT THE NEEDLE BUTTON POPPED OUT WITH IN AN HOUR OF PUTTING THE VGO DEVICES ON. PATIENT STATED THAT TODAY SHE ALSO HAD THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912891 ↗
• MalfunctionMay 24, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PATIENT REPORTED AN ISSUE WITH TWO V-GO DEVICES THAT THE NEEDLE BUTTON REPORTEDLY RETRACTED OWN ITS OWN PRIOR TO THE 24HRS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871403 ↗
• MalfunctionMay 20, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT WITH TWO V-GO'S, THE NEEDLE BUTTON POPPED OUT MIDWAY THROUGH THE DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11855391 ↗
• MalfunctionMay 20, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT TWO V-GO'S ON(B)(6) 2021 AND (B)(6) 2021 THE NEEDLE BUTTON POPPED OUT MIDWAY THROUGH THE DAY. THE PATIENT CONFIRMED THAT SHE IS PRESSING ON THE RAISED CIRCULAR BUMP OF THE NEEDLE BUTTON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854577 ↗

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