V-Go Disposable Insulin Delivery V-Go 30 (REF 8560-9600-02)Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00385609600029), received between Mar 28, 2019 and Jun 26, 2023 — classified as 5 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (14 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT EIGHT V-GOS FELL OFF IN LESS THAN THREE HOURS OF WEAR. THE EXACT EVENT DATES WERE NOT REPORTED. THE PATIENT REPORTED THAT THEY WEAR V-GO ON THEIR ARMS, THIGHS, AND ABDOMEN. THE PATIENT REPORTED THAT THEY SHOWER, DRY OFF, USE AN ALCOHOL WIPE AND THEN AIR DRIES BEFORE APPLYING THE V-GO. NO DEVICES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION BECAUSE THEY WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199205 ↗
• MalfunctionJan 31, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THEY ARE HAVING ISSUES WITH THE NEEDLE OF THEIR V-GO NOT STAYING IN (RELEASING). THE PATIENT REPORTED THE ISSUE IS CAUSING THEM PAIN AND BRUISING. THE PATIENT STATED THEY MUST HOLD THE DEVICE FOR THE INSULIN TO RELEASE WHICH CAUSES PAIN. THE DEVICE WAS REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION, HOWEVER TO DATE HAS NOT BEEN RECEIVED.

  Patient problems: Bruise/Contusion; Pain

  MAUDE report 16272886 ↗
• MalfunctionMar 23, 2022Premature Separation; Premature Separation

  ON 3/7, THE PATIENT HAD 2 V-GO 30 DEVICES FALL OFF -- ONE THAT WAS APPLIED FOR 2 HOURS BETWEEN 8AM-10 AND ANOTHER THAT FELL OFF AFTER 5 HOURS BETWEEN 10AM AND 3PM. THE PATIENT MENTIONED THAT HE COULD FEEL THE NEEDLE STICKING IN AND OUT WHEN THE V-GO 30 BECAME LOOSE. THE PATIENT CONFIRMED THAT HE HAS BEEN USING AN ALCOHOL SWAB PRIOR TO APPLYING THE V-GO 30 DEVICES AND STATED THAT THE V-GO DEVICES HAVE FALLEN OFF PATIENT STOMACH, ARM, HIP AND SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13859931 ↗
• MalfunctionMar 18, 2022Premature Separation; Premature Separation

  THE PATIENT REPORTED 6 TIMES THE V-GO DEVICES FELL OFF. THE PATIENT USES ALCOHOL WIPES AND LETS IT DRY PRIOR TO USING V-GO . THE PATIENT AVOIDS PLACING V-GO IN AREAS OF HER BODY CONTAINING EXCESS SKIN, MUSCLE, AND BONE. THE PATIENT DID NOT HAVE ANY INTERFERENCE WITH HER CLOTHING. THE PATIENT IS UNSURE HOW LONG SHE WORE THE DEVICES PRIOR TO THEM COMING OFF BESIDES THE ONE TIME IT CAME OFF AROUND NOON AND THE PATIENT NOTICED HER BLOOD SUGAR WENT HIGH. THE PATIENT EXPLAINED WHEN THAT OCCURRED PATIENT STARTED TO FEEL COLD, COOLED, AND KIND OF SLUGGISH.

  Patient problems: Hyperglycemia

  MAUDE report 13805139 ↗
• MalfunctionFeb 4, 2022Premature Separation; Premature Separation

  PATIENT REPORTED THAT SHE APPLIES HER V-GO 30 DEVICE USING PROPER APPLICATION PROCEDURES AND SOMETIMES THE V-GO DEVICE IMMEDIATELY FALLS OFF AND SOMETIMES IT IS AFTER HOURS, THE TIME ALWAYS VARIES. PATIENT REPORTED THAT SHE MOVES HER V-GO SIDE TO SIDE AND WEARS IT ON HER ABDOMEN, INNER THIGH, AND THE BACK OF HER ARM (YESTERDAY'S EVENT SHE WAS WEARING IT ON HER LEFT ARM SPECIFICALLY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13450391 ↗
• MalfunctionOct 8, 2021Premature Separation; Premature Separation

  THE MOTHER OF THE PATIENT, STATED THAT THE PATIENT APPLIED HIS FIRST V-GO 30 FOR THE FIRST TIME TODAY AROUND 10:30-11:00AM AND THE V-GO FELL OFF AFTER 2 HOURS OF USE. THE REPORTER MENTIONED THAT THE PATIENT PERSPIRES A LOT AND THE V-GO WAS APPLIED ABOUT THE LENGTH OF THE SIDE OF A HAND BELOW THE NIPPLE BECAUSE THE PATIENT HAS TOO MUCH HAIR ON HIS STOMACH AND ABDOMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12597597 ↗
• MalfunctionMay 5, 2021Premature Separation; Premature Separation

  PATIENT WIFE REPORTED THAT HER HUSBAND'S V-GO DEVICE FELL OFF ABOUT 20 HRS INTO THERAPY AROUND 2:30PM. PATIENT WIFE STATED THAT THIS IS THE FIRST TIME THIS HAS HAPPENED AND ALSO STATED THAT PATIENT SWEATS A LOT WHEN HE WORKS. PATIENT WIFE STATED THAT PATIENT PLACES V-GO DEVICE ON HIS ABDOMEN AND DID CLEAN AREA BEFORE APPLYING V-GO DEVICE. PATIENT WIFE STATED THAT PATIENT DID DISCARD V-GO DEVICE AND REPLACED IT WITH ANOTHER V-GO DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776453 ↗
• MalfunctionApr 2, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT HAD ABOUT FOUR V-GO 30 DEVICES THAT THE NEEDLE RELEASED ON IT'S OWN. THE PATIENT STATED THAT THE ALL THE DEVICES IN QUESTION CAME FROM THE SAME BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11608609 ↗
• MalfunctionMar 29, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THE NEEDLE BUTTON RELEASED BEFORE THE COMPLETION OF 24 HOURS ON (B)(6) 2021. THE PATIENT SAID THAT V-GO WAS ABLE TO BE USED FOR MEALTIME INSULIN AT LUNCH AND LATER THE NEEDLE BUTTON RELEASED. THE PATIENT COULD NOT SAY WHEN THAT HAPPENED. PATIENT NOTICED HIS BLOOD SUGAR WENT UP DUE TO NOT GETTING ANY INSULIN. PATIENT PUT ON A NEW, FILLED V-GO TO BRING HIS BLOOD SUGAR DOWN. PATIENT SAID HE EXPERIENCED POLYURIA, POLYDIPSIA, AND FELT DEHYDRATED. HIS BLOOD SUGAR EVENTUALLY CAME BACK DOWN. PATIENT SAID A NORMAL RANGE FOR HIM IS ABOUT 80 TO 180.

  Patient problems: Hyperglycemia

  MAUDE report 11580948 ↗
• MalfunctionMar 29, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PATIENT STATED TODAY ON THE FIRST V-GO THE NEEDLE BUTTON RELEASED RIGHT AWAY, THEN HE PUT ON ANOTHER V-GO AND IT LASTED TILL LUNCH WHEN PATIENT GAVE HIMSELF HIS BOLUS CLICKS. PATIENT THEN NOTICED LATER THAT THE NEEDLE BUTTON HAD RELEASED AGAIN, AND HIS BLOOD SUGAR WENT UP INTO THE 300'S. PATIENT PUT ON ANOTHER V-GO AT ABOUT 3:20PM. PATIENT IS AT 310 NOW AT 3:45PM, AND WAS AT 240 WHEN HE PUT THE V-GO ON. PATIENT IS STILL GOING UP, BUT PATIENT SAID IT WILL COME DOWN AGAIN AFTER THE V-GO HAS BEEN ON A BIT LONGER.

  Patient problems: Hyperglycemia

  MAUDE report 11580946 ↗
• MalfunctionMar 1, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PATIENT NOTICED AT 4PM THAT THE NEEDLE BUTTON ACCIDENTLY RELEASED PRIOR TO THE COMPLETION OF THE 24-HOUR PERIOD. PATIENT STATED CHECKED HER BLOOD SUGAR AT 4:15PM AND IT WAS 240.

  Patient problems: Hyperglycemia

  MAUDE report 11392886 ↗
• MalfunctionJan 14, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THE NEEDLE BUTTON RELEASED BEFORE THE 24 HOUR PERIOD TODAY. THE PATIENT INDICATED THAT THIS HAPPENED AFTER HAVING THE V-GO FOR APPROXIMATELY 13 HOURS. THE PATIENT WAS ADVISED TO REMOVE THE V-GO AFTER THE CALL AND PLACE A NEW V-GO ON HER BODY. THE PATIENT INDICATED THAT SHE USES THE V-GO ON HER ABDOMEN. THE PATIENT INDICATED THAT SHE IS USING THE V-GO SINCE YESTERDAY. THE PATIENT THAT SHE EXPERIENCED HYPERGLYCEMIA TODAY. THE PATIENT REPORTED THE FOLLOWING READINGS TODAY (B)(6) 2020: -AROUND 9:30 A.M. OF 215-BEFORE DINNER OF 267-DURING THE CALL AT 7:43 P.M. OF 334. THE PATIENT INDICATED THAT HER NORMAL READINGS ARE BETWEEN 140-200.

  Patient problems: Hyperglycemia

  MAUDE report 11169632 ↗
• MalfunctionJan 4, 2021Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THE V-GO FELL OFF AT 4:00 A.M. THIS MORNING (B)(6) 2021, AFTER 18 HOURS OF WEARING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11112583 ↗
• MalfunctionOct 19, 2020Premature Separation; Premature Separation

  PATIENT STATED THE V-GO FELL OFF WITHIN AN HOUR AND A HALF FROM HAVING IT ON THE ABDOMEN. PATIENT IS CLEANING THE SITE BEFORE APPLYING THE V-GO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10697103 ↗
• InjurySep 23, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  PATIENT REPORTED THAT HE HAD 2 DEVICES WHICH STOPPED DELIVERING INSULIN; HE NOTICED HIS BG WAS 300 AND INTO THE LOW 400S AND THE GRAY INDICATOR WAS NOT MOVING. PATIENT EXPERIENCED HIGHS ON (B)(6) 2020. THE PATIENT STATED THAT HE WAS PRESCRIBED V-GO 40 BUT THE PHARMACY DISPENSED V-GO 30 DEVICES IN ERROR TWO WEEKS AGO. THE PATIENT HAS BEEN USING V-GO 30 FOR 2 WEEKS. THE PATIENT REPORTED THAT HE'S BEEN EXPERIENCING HIGHS BETWEEN 300-400 ALL DAY EACH DAY. ON A NORMAL DAY THE PATIENT'S NUMBERS ARE AROUND 180. PATIENT STATED THAT HE DIDN'T EXPERIENCE ANY SYMPTOMS FOR THE HYPERGLYCEMIC EVENTS AND THAT HIS GLUCOSE MONITOR ALERTED HIM ABOUT HIS NUMBERS. PATIENT CONFIRMED HE DID NOT PRESS OR HIT THE NEEDLE RELEASE BUTTON, MAKING THE NEEDLE RETRACT AND INSULIN DELIVERY CEASE. PATIENT WEARS THE V-GO DEVICE ON HIS STOMACH.

  Patient problems: Hyperglycemia

  MAUDE report 10573093 ↗
• MalfunctionSep 15, 2020Premature Separation; Premature Separation

  PATIENT REPORTS THAT THE ADHESIVE PAD DOES NOT STAY ATTACHED TO HER BODY CAUSING HER APPLICATION SITE ISSUES OF PAIN/ DISCOMFORT. PATIENT WEARS HER V-GO ON HER ABDOMEN, PROPERLY PREPARES THE SITE BEFORE APPLICATION, AND REPORTS THAT WITHIN 1 TO 5 HOURS OF WEARING HER V-GO THE ADHESIVE BECOMES LOOSE CAUSING THE NEEDLE TO MOVE AND CAUSE THE PAIN/DISCOMFORT.

  Patient problems: Pain

  MAUDE report 10534466 ↗
• MalfunctionSep 14, 2020Premature Separation; Premature Separation

  PATIENT REPORTED THAT ON (B)(6) 2020, HER AIR CONDITIONER WAS BROKE AND AFTER 3 OR 4 HOURS OF USE ADHESIVE PAD DID NOT STAY ATTACHED TO THE BODY AND THE V-GO FELL OFF. PATIENT REPORTS THAT THE V-GO WAS ON HER ABDOMEN AND SHE WAS PERSPIRING MORE THAN USUAL ON THIS PARTICULAR DAY. PATIENT DISCARDED THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10529051 ↗
• MalfunctionAug 26, 2020Premature Separation; Premature Separation

  THEE PATIENT STATED THE V-GOS WERE ARE STICKING TO HER ABDOMEN, SHE CHANGED TO HER ARMS, PATIENT ESTIMATED THAT ABOUT FOUR OR FIVE V-GOS FELL OFF HER ABDOMEN, ON AVERAGE AFTER BEING ON FOR ABOUT EIGHT HOURS. THE PATIENT HAD A RASH THAT DEVELOPED INTO BLISTERS AND RED WELTS. THE PATIENT HAS BEEN ON THE V-GO SINCE (B)(6) OF 2013 AND THIS IS THE FIRST TIME SHE HAS HAD THIS PROBLEM. PATIENT THINKS THEY FELL OFF BECAUSE OF THE BLISTERS AND WELTS ON HER ABDOMEN.

  Patient problems: Rash

  MAUDE report 10454915 ↗
• MalfunctionAug 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT MENTIONED THAT SHE IS EXPERIENCING HYPERGLYCEMIA AND THE BOLUS DELIVERY BUTTON LOCKING OUT BEFORE 18 CLICKS. THE PATIENT MENTIONED THAT SHE KEEPS 5 PRE-FILLED V-GO'S IN HER REFRIGERATOR BUT IS UNSURE OF THE INSULIN BRAND NAME TO CONFIRM STORAGE CONDITIONS. THE PATIENT PROVIDED THE FOLLOWING READINGS ON 7/9 - 7/11 BUT STATED THAT SHE WAS NOT ON V-GO WHILE CHECKING HER READINGS THROUGH FINGER PRICKS, ALSO STATING THAT 7/09 WAS WRITTEN DOWN AS THE START DATE -- 7/09 - 415 AT 5:09AM, 350 AT 8:02AM, 450 AT 3:15PM, 500 AT 6:45PM; 7/10 - 446 AT 1:00AM, 403 AT 6:45AM, 393 AT 3:10PM, 381 AT 9:25PM; 7/11 - 434 AT 1:10AM. THE PATIENT PROVIDED THE FOLLOWING READINGS WHILE ON V-GO -- DAY 3 - 429 BEFORE BREAKFAST; DAY 4 - "HIGH" BEFORE BREAKFAST, 318 BEFORE LUNCH, 436 BEFORE DINNER; DAY 5 - "HIGH" BEFORE BREAKFAST, 407 BEFORE LUNCH, 499 BEFORE DINNER; DAY 6 - 454 BEFORE BREAKFAST, 448 BEFORE LUNCH, "HIGH" BEFORE DINNER; DAY 7 - 377 BEFORE BREAKFAST, "HIGH" BEFORE LUNCH, 407 BEFORE DINNER, DAY 8 - 326 BEFORE BREAKFAST. 289 BEFORE LUNCH, 347 BEFORE DINNER. THE PATIENT MENTIONED A NURSE ADVISED HER TO GO TO THE HOSPITAL ON 7/14 AND SHE WENT TO THE EMERGENCY ROOM WHERE THEY GAVE HER AN I

  Patient problems: Hyperglycemia

  MAUDE report 10394416 ↗
• InjuryDec 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT REPORTED HE WENT TO HIS LOCAL URGENT CARE CENTER ON (B)(6) 2019 AND WAS TOLD HE HAD AN INFECTION AT THE REPORTED VGO SITE. PATIENT WAS GIVEN ORAL ANTIBIOTICS FOR THE INFECTION - AMOXICILLIN.

  Patient problems: Unspecified Infection

  MAUDE report 9506981 ↗
• MalfunctionNov 20, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT STARTED V-GO 30 ON (B)(6) 2019 AND ON (B)(6), THE NEEDLE BUTTON POPPED OUT WITH THE V-GO APPLIED TO HER LEFT THIGH.

  Patient problems: No Information

  MAUDE report 9350564 ↗
• MalfunctionNov 20, 2019Premature Separation; Premature Separation

  PATIENT REPORTED THAT A V-GO DEVICE TODAY FELL OFF. PATIENT STATED SHE DOES CLEAN THE LOCATION WITH THE ALCOHOL SWABS AND ALLOW THE AREA TO DRY PRIOR TO ATTACHING ON THE V-GO.

  Patient problems: No Information

  MAUDE report 9350563 ↗
• MalfunctionNov 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT REPORTED THAT SINCE (B)(6) 2019 THE FIRST DAY UNDER V-GO THERAPY, THE DEVICE KEEPS COMING LOOSE FROM HER BODY. IN THE FIRST DAY THE PATIENT PUT THE DEVICE ON AT 11:00 A.M. AND AT 7:00 P.M. THE DEVICE CAME LOOSE FROM PATIENT SKIN. IN THE SECOND DAY, PATIENT PUT THE DEVICE AT 11:00 A.M. AND THE DEVICE CAME LOOSE FROM PATIENT SKIN AT 5:00 P.M. PATIENT SWEATS A LOT. THERE WAS NO EXTRA MOVEMENTS OR EXERCISE WAS PERFORMED WHILE USING THE DEVICE, NO INTERFERENCE WITH CLOTHING.

  Patient problems: No Information

  MAUDE report 9297689 ↗
• MalfunctionOct 25, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT MENTIONED THAT SHE STARTED V-GO 30 ON (B)(6) 2019. THE PATIENT STATED THAT SHE TOSSES AND TURNS AT NIGHT WHILE SLEEPING AND THE V-GO CAME OFF OF HER STOMACH ON (B)(6) IN THE MIDDLE OF THE NIGHT.

  Patient problems: No Information

  MAUDE report 9239355 ↗
• MalfunctionOct 22, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED THAT HE EXPERIENCED THE NEEDLE RETRACTING ON ITS OWN. THE PATIENT STATED HE ISN'T SURE IF HE RETRACTED THE NEEDLE IN ERROR.

  Patient problems: No Information

  MAUDE report 9218514 ↗

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