V-Go Disposable Insulin Delivery V-Go 40 (REF 8560-9400-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 355 adverse event reports that list this exact device (DI 00385609400018), received between Oct 29, 2018 and Dec 3, 2025 — classified as 33 injuries, 322 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (141 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 355 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THE NEEDLE RELEASE BUTTON POPPED UP UNEXPECTEDLY (NEEDLE BUTTON RELEASED) FOR THREE OF THEIR V-GO 40 DEVICES AT DIFFERENT TIMES. THE EXACT DATES OF EACH EVENT WERE NOT REPORTED. IT WAS REPORTED THAT THE DEVICES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. TO DATE, THEY HAVE NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706041 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THEY HAD A LOW BLOOD SUGAR OF 48 (MG/DL) THIS MORNING AFTER PUTTING ON THE V-GO 40 PATCH, SHE DRANK SOME JUICE AND ATE SOME SUGAR AND GOT IT BACK UP TO 167. THE SAME AFTERNOON SHE HAD ANOTHER LOW EPISODE. IT WAS REPORTED THAT THE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hypoglycemia; Shaking/Tremors

  MAUDE report 22555142 ↗
• MalfunctionApr 17, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT WHEN PRESSING DOWN ON NEEDLE RELEASE BUTTON THE NEEDLE WOULD NOT ENGAGE INTO HIS SKIN. THE PATCH WOULD STAY ON HIS BODY, BUT THE NEEDLE WOULD POP OFF FROM TIME TO TIME AND HE WOULD HAVE TO POP IT BACK (IN). HE HAS HAPPENED TO HIM 9 TIMES SO FAR WITH HIS NEW BOX AND IT HAS NEVER HAPPENED TO HIM BEFORE. IT WAS REPORTED THAT DEVICE SAMPLES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. TO DATE, THE SAMPLES HAVE NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859017 ↗
• MalfunctionMar 14, 2025Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEIR V-GO PRESCRIPTION FROM THE PAST COUPLE OF WEEKS (EXACT DATE UNKNOWN) IN WHICH FOUR V-GO DEVICES DID NOT ADHERE TO THEIR SKIN AND FELL OFF. IT WAS REPORTED THAT A DEVICE SAMPLE WAS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER, TO DATE, THE DEVICE SAMPLE HAS NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607452 ↗
• MalfunctionDec 10, 2024Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT AT LEAST SIX OF THEIR V-GO 40 DEVICES FELL OFF. THE PATIENT STATED THAT THEY USED ALCOHOL BEFORE APPLYING THE V-GO DEVICES AND THEY WILL NOT STAY ON THEIR SKIN. IT WAS REPORTED THAT NO DEVICES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893979 ↗
• MalfunctionNov 12, 2024Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT ONE OF THEIR V-GO 40 DEVICES FELL OFF. IT WAS REPORTED THAT THE DEVICE 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 20663365 ↗
• MalfunctionOct 16, 2024Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEY ARE EXPERIENCING EVERY V-GO 40 DEVICE FALLING OFF FROM THEIR MOST RECENT BOX. THE PATIENT EXPRESSED THAT SHE IS FAMILIAR WITH HOW TO USE THE DEVICE. IT WAS REPORTED THAT THE DEVICES WOULD NOT STAY ON FOR THE 24-HOUR WEAR PERIOD. IT WAS REPORTED THAT DEVICES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20464792 ↗
• MalfunctionSep 26, 2024Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT TWO V-GO 40 DEVICES FELL OFF WHILE THE PATIENT WAS SLEEPING. THE PATIENT REPORTED THAT THE NEEDLE POKED HIM. IT WAS REPORTED THAT THE DEVICES WERE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER, TO DATE, HAVE NOT BEEN RECEIVED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20311652 ↗
• MalfunctionSep 10, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THE V-GO 40 DEVICES WERE HAVING ISSUES. IT WAS REPORTED THAT THE BUTTON WOULD POP OFF (RELEASE) AND THEY WERE NOT ABLE TO GET INSULIN. THE PATIENT REPORTED THAT THIS HAPPENED FOUR TIMES, HOWEVER NO SPECIFIC EVENT DATES WERE REPORTED. IT WAS REPORTED THAT ONE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER. HOWEVER, TO DATE, NO DEVICE HAS BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180268 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED HIGH BLOOD SUGARS ON (B)(6) 2024 TO 700 (MG/DL). THE PATIENT REPORTED HER SUGARS WERE 100 IN THE MORNING, THEN SHE GOT IMAGING AND CONTRAST DYE, THE EVENING SUGARS WERE 400. SHE SAID THE "PUMP WASN'T DOING ANYTHING" SO SHE TOOK IT OFF AND TOOK HER REGULAR INSULIN REGIMEN. IT WAS REPORTED THAT THE DEVICE SAMPLES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hyperglycemia

  MAUDE report 20129331 ↗
• MalfunctionAug 23, 2024Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEIR V-GO 40 DEVICE KEEPS FALLING OFF THEIR ARM. THE PATIENT STATED HE HAS GONE THROUGH 12 DEVICES IN THE PAST SIX DAYS. 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 20051147 ↗
• MalfunctionJun 5, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THERE HAS BEEN AN INSTANCE WHERE THE NEEDLE OF THEIR V-GO RETRACTED ON ITS OWN (RELEASED). IT WAS REPORTED THAT THE DEVICE 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 19466882 ↗
• MalfunctionMay 9, 2024Premature Separation; Premature Separation

  THE PATIENT NOTICED THE V-GO NEEDLE BUTTON HAD RELEASED PREMATURELY, SO HE COULD NOT USE IT FOR THE REST OF THE DAY. HE DID NOT HIT IT ON ANYTHING, AND THINKS IT WAS A FAULTY V-GO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280634 ↗
• MalfunctionMar 19, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THE NEEDLE OF THEIR V-GO DEVICE POPPED OUT (RELEASED) BEFORE THE 24-HOURS WEAR PERIOD. IT WAS REPORTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18930323 ↗
• MalfunctionNov 8, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THE NEEDLE BUTTON OF THEIR V-GO 40 RELEASED. THE PATIENT REPORTED THAT THEY WERE JUST STANDING, AND THEY HEARD IT CLICK/POP OUT. IT WAS REPORTED THAT THE DEVICE 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 18093427 ↗
• MalfunctionOct 12, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THEY HAD TWO OCCASIONS IN WHICH THE NEEDLE RELEASED FROM THEIR V-GO 40. THE PATIENT STATED THAT THE ISSUES OCCURRED ON (B)(6) 2023 AND (B)(6) 2023. THE FIRST DAY THE V-GO DEVICE WAS ON THE PATIENT'S STOMACH WHILE SHE WAS SLEEPING AND WHEN SHE TURNED AROUND THE NEEDLE CAME OUT AND POKED HER. THE SECOND TIME THE PATIENT WAS WASHING CLOTHES AND WHEN THEY TOOK THE CLOTHES OUT OF THE LAUNDRY THE NEEDLE RELEASED AND POKED HER STOMACH, AS WELL. THE PATIENT STATED THAT THERE ARE NO DEVICES AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17923911 ↗
• MalfunctionOct 3, 2023Premature Separation; Premature Separation

  THE PATIENT STATED SINCE HE STARTED USING THIS ORDER AROUND THE FIRST OF SEPTEMBER 6 OF THE V-GO 40S HAVE FALLEN OFF PREMATURELY. HE STATED HE HAS USED THIS PRODUCT FOR ABOUT 5 YEARS AND DOES NOT RECALL THIS EVER HAPPENING BEFORE. IT WAS REPORTED THAT THE 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 17860538 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THE V-GO 40 IS GIVING HER TOO MUCH INSULIN RESULTING IN OVERDOSE AND HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED AT INTAKE. IT WAS REPORTED THAT NO DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hypoglycemia

  MAUDE report 17788743 ↗
• MalfunctionSep 21, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THE ADHESIVE OF THE V-GO IS NOT STICKING TO THEIR SKIN. THE PATIENT REPORTED THAT THE DEVICE FELL OFF AFTER A FEW HOURS OF WEAR, OR IN THE SHOWER. NO SPECIFIC EVENT DATES WERE REPORTED AND ADDITIONAL INFORMATION ON SKIN PREPARATION PRIOR TO V-GO PLACEMENT IS ALSO UNKNOWN. IT WAS REPORTED THAT NO DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788739 ↗
• MalfunctionAug 28, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEY HAD MULTIPLE V-GO 40 DEVICES THAT DID NOT STAY ATTACHED TO THEIR BODY (FELL OFF). THE DEVICES WERE REPORTED TO BE 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 17632135 ↗
• MalfunctionAug 23, 2023Premature Separation; Premature Separation

  A PHARMACIST CALLED TO REPORT THAT A PATIENT HAS HAD 10 V-GO 40'S POP OFF WITHIN THE LAST 15 DAYS. HE HAS BEEN USING V-GO 40 FOR ABOUT 3 YEARS. SHE REQUESTED THAT WE SHIP 10 VGO 40'S TO THE PATIENT. SHE DOES NOT KNOW IF HE HAS ANY TO RETURN. ALL 10 V-GO'S WERE FROM THE SAME ORDER. 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 17607583 ↗
• MalfunctionAug 22, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THREE V-GO DEVICES DID NOT STAY ATTACHED TO THEIR BODY AND FELL OFF. IT WAS REPORTED THAT THE DEVICES WERE FROM THE SAME BOX. THE PATIENT REPORTED THAT THEY WERE INDOORS ALL DAY WHEN TWO DEVICES FELL OFF, SO THEY DO NOT THINK IT'S DUE TO PERSPIRATION. IT WAS REPORTED THE DEVICES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596140 ↗
• MalfunctionAug 10, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEY HAD THREE V-GO 40 DEVICES FALL OFF ON THE SAME DAY. IT WAS REPORTED THAT THE SKIN WAS PREPPED WITH AN ALCOHOL WIPE AND AIR DRIED PRIOR TO APPLICATION. IT WAS REPORTED THAT A 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 17501398 ↗
• MalfunctionAug 2, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THEY HAD TWO V-GO 40 DEVICES IN WHICH THE NEEDLE BUTTON RELEASED DURING USE. THE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442402 ↗
• MalfunctionAug 2, 2023Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT THEY HAD ONE V-GO 40 DEVICE FALL OFF ABOUT FIVE HOURS AFTER APPLICATION. IT WAS REPORTED THAT THE DEVICE FELL OFF WHEN THEY WERE GETTING DRESSED AND THERE WAS INTERFERENCE WITH CLOTHING AND INCREASED MOVEMENT. THE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442215 ↗

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