V-Go Disposable Insulin Delivery V-Go 40 (REF 8560-9600-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00385609600012), received between Nov 14, 2018 and Sep 13, 2022 — classified as 4 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (16 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THE DEVICE RELEASED BEFORE 24-HOURS. PATIENT DOES NOT REMEMBER HOW LONG HE WORE IT BEFORE IT RELEASED. THE PATIENT REPORTED THAT PRODUCT SAMPLES ARE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. HOWEVER; TO DATE, NO PRODUCT SAMPLE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411271 ↗
• MalfunctionSep 22, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE SPOUSE REPORTED THAT THE NEEDLE BUTTON ACCIDENTLY RELEASED PRIOR TO THE COMPLETION OF THE 24-HOUR PERIOD. PATIENT HAS BEEN USING V-GO DEVICE FOR ONE DAY AND WAS NURSE/CDE TRAINED AT THE OFFICE OF HER HCP. PATIENT WAS WEARING HER V-GO 40 DEVICE ON HER ABDOMEN AND WAS UNSURE HOW LONG IT WAS BEFORE THE NEEDLE BUTTON RELEASED. THE V-GO 40 DEVICE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512812 ↗
• MalfunctionAug 6, 2021Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT ON (B)(6) 2021 APPROXIMATELY 21 HOURS AFTER APPLYING THE V-GO DEVICE, THE ADHESIVE PAD DID NOT STAY ATTACHED TO THE BODY. PATIENT REPORTED THAT ON (B)(6) 2021 SHE WAS TRAINED ON V-GO USE BY HER NURSE PRACTITIONER AND HIS OFFICE ON PROPER V-GO USE AND THE FILL, WEAR AND GO PROCEDURE AND APPROXIMATELY 21 HOURS LATER THE V-GO BECAME DETACHED FROM HER ABDOMEN WHERE IT WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12287383 ↗
• MalfunctionJul 15, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THE NEEDLE BUTTON HAS RELEASED ON IT'S OWN ON THREE V-GO 40 DEVICES WITH THE MOST RECENT ONE HAPPENING THIS MORNING. PATIENT WAS NOT ABLE TO ADVISE WHAT DATES THE OTHER 2 DEVICES. THE ONE V-GO 40 DEVICE IN QUESTION IS AVAILABLE FOR COLLECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177693 ↗
• MalfunctionJul 6, 2021Premature Separation; Premature Separation

  THE PATIENT STATED THAT FOR THE PAST MONTH, 10 V-GO DEVICES THE ADHESIVE IS NOT STICKING AND THEY ARE FALLING OFF PATIENT STOMACH AND ARM WITHIN THE FIRST 6 HOURS. THE PATIENT CONFIRMED THAT HE USES AN ALCOHOL SWAB TO CLEAN THE INFUSION SITE PRIOR TO APPLYING A V-GO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12123345 ↗
• MalfunctionJun 30, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT SINCE THIS PAST (B)(6) 2021, PATIENT STATED THAT THE NEEDLE BUTTON ON ABOUT 9 V-GO 40 DEVICES RELEASED ON IT'S OWN. THE PATIENT STATED THAT THE MOST RECENT ONE RELEASED ON ITS OWN AFTER SLIGHTLY BUMPING IT AND ALL THE OTHERS WERE JUST RANDOM. THE PATIENT WEARS THE V-GO ON HIS ABDOMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094355 ↗
• MalfunctionJun 18, 2021Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT TWO V-GO DEVICES FELL OFF HER ABDOMEN TODAY. THE PATIENT EXPLAINED SHE PLACED A V-GO ON AT 7AM THIS MORNING AND WORE IT FOR 8 HOURS AND THEN THE DEVICE FELL OFF. THE PATIENT STATED THAT SHE WAS SWEATING AT THE TIME IT FELL OFF. THE PATIENT THEN STATED SHE REPLACED THAT DEVICE WITH A NEW ONE AND THAT REPLACEMENT DEVICE FELL OFF AS WELL AFTER 6 HOURS. THE DEVICES WERE DISCARDED BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12024778 ↗
• MalfunctionMay 24, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THE NEEDLE BUTTON RELEASED ON IT'S OWN AFTER WEARING IT FOR ABOUT 12 HOURS ON 20 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872242 ↗
• MalfunctionApr 9, 2021Premature Separation; Premature Separation

  PATIENT STATED THAT THE V-GO SHE APPLIED THE NIGHT OF (B)(6) 2021 FELL OFF IN THE SHOWER ON (B)(6) 2021, 7 HOURS AFTER IT WAS APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11641089 ↗
• InjuryApr 9, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PATIENT REPORTED THAT ONE DAY IN (B)(6) PATIENT EXPERIENCED A BLOOD GLUCOSE LEVEL READING OF 180, AFTER THE BUTTON ON HER V-GO POPPED UP BEFORE THE END OF THE 24-HOUR CYCLE. PATIENT DID NOT RECALL THE DAY OR TIME OF THE EVENT. PATIENT STATED THAT HER NORMAL BLOOD GLUCOSE LEVELS RANGE BETWEEN 70 AND 130.

  Patient problems: Hyperglycemia

  MAUDE report 11641088 ↗
• MalfunctionMar 17, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THE V-GO 40 DEVICE THAT THE NEEDLE BUTTON RELEASED ON IT'S OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11503809 ↗
• MalfunctionMar 8, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PATIENT REPORTED ON (B)(6) 2021 THE NEEDLE BUTTON RELEASED AFTER 4 HOURS OF WEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11434998 ↗
• MalfunctionJan 28, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PATIENT REPORTED THE NEEDLE BUTTON POPPED UP AFTER 6 TO 7 HOURS OF WEAR. PATIENT STATED THE V-GO WAS APPLIED TO THE SIDE OF HIS ABDOMEN AND THAT HE NOTICED IT WHEN HE AWAKENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11243183 ↗
• MalfunctionDec 8, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PATIENT STATED THAT FROM HIS MOST RECENT V-GO BOX HE EXPERIENCE THE NEEDLE BUTTON POPPING OUT BEFORE 24 HOURS ON TWO OF HIS V-GO'S. PATIENT STATED THAT JUST WHEN HE WAS ABOUT TO GIVE HIMSELF HIS BOLUS CLICKS PATIENT NOTICED THAT THAT THE NEEDLE BUTTON POPPED OUT. PATIENT STATED THAT HE IS APPLYING THE VGO DEVICE ON HIS ABDOMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10971590 ↗
• InjuryOct 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT REPORTED THE BOLUS DELIVERY BUTTONS LOCKED OUT ON PATIENT WHILE USING THE V-GO AND PATIENT EXPERIENCED HYPERGLYCEMIA. PATIENT STATED ON A NORMAL DAY HER NUMBERS ARE AROUND 200 HOWEVER ON THIS DAY HER NUMBERS WERE AROUND 560. PATENT STATED LAST WEEK HER NUMBERS WERE AROUND 600. PATIENT SAYS SHE WAS DIRECTED BY HER DOCTOR TO TAKE 50 UNITS OF NOVOLOG TO BRING HER NUMBER BACK DOWN. PATIENT WAS ADMITTED AND DISCHARGED ON (B)(6) 2020. PATIENT EXPERIENCED HOT SWEATS AND PATIENT STOMACH FELT SICK. PATIENT WORE V-ON HER TUMMY WHILE SHE WAS HOSPITALIZED.

  Patient problems: Hyperglycemia

  MAUDE report 10746784 ↗
• MalfunctionOct 2, 2020Premature Separation; Premature Separation

  THIS PATIENT REPORTED THAT ON (B)(6) 2020 THE V-GO 40 DEVICE CAME OFF WHILE THE PATIENT WAS DOING ARD WORK AND WAS PERSPIRING. THE PATIENT PROPERLY PREPARED THE APPLICATION SITE PRIOR TO APPLYING THE V-GO DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10619446 ↗
• MalfunctionSep 21, 2020Premature Separation; Premature Separation

  PATIENT REPORTS THAT SHE WAS TRAINED BY A V-GO REPRESENTATIVE THIS MORNING AND AFTER TWO HOURS OF USE ADHESIVE PAD DID NOT STAY ATTACHED TO THE BODY. PATIENT CONFIRMS THAT PROPER SITE PREPARATION WAS COMPLETED AND THERE WAS NO INCREASED MOVEMENT OR INTERFERENCE WITH CLOTHING. PATIENT WAS WEARING THE V-GO ON HER ABDOMEN WHEN IT FELL OFF. PATIENT IS A FORMER SURGICAL NURSE AND BELIEVES THAT THE WEIGHT OF THE FILLED V-GO IS TOO MUCH FOR THE TYPE OF ADHESIVE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10560758 ↗
• MalfunctionSep 17, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT ON 8/16, THE NEEDLE BUTTON POPPED OUT ABOUT 4 HOURS INTO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10546254 ↗
• MalfunctionSep 14, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT OVER THE LAST WEEK TWO OF HER V-GOS HAD THE NEEDLE BUTTON POP OUT BEFORE THE 24 HOUR PERIOD WAS UP. IT HAPPENED WITHIN FIVE TO THIRTY MINUTES OF PUTTING THEM ON. THE FIRST OCCURRENCE WAS ON (B)(6) 2020 AND THE SECOND WAS ON (B)(6) 2020. PATIENT WEARS THE V-GO ON THE BACK OF THE ARM. PATIENT THREW AWAY THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10529054 ↗
• MalfunctionAug 5, 2020Premature Separation; Premature Separation

  THE PATIENT STATED THE V-GO 40 FELL OFF AFTER 3 HOURS ON HER STOMACH. THE PATIENT STATED THAT THE INFUSION SITE WAS CLEANED WITH AN ALCOHOL SWAB PRIOR TO APPLYING THE V-GO.

  Patient problems: No Information

  MAUDE report 10367176 ↗
• MalfunctionJul 22, 2020Premature Separation; Premature Separation

  THE PATIENT REPORTED THAT HE NOTICED THAT THE V-GO WAS COMING LOOSE FROM HIS SKIN. THE PATIENT HAD THE V-GO APPLIED TO HIS ABDOMEN AND STATED THAT ALL THE SWEAT FROM WORKING OUTSIDE LOOSENED THE ADHESIVENESS.

  Patient problems: No Information

  MAUDE report 10308908 ↗
• MalfunctionJul 20, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT REPORTED THAT THE NEEDLE BUTTON, OR START BUTTON, CAME BACK UP ON SEVERAL V-GO'S, ABOUT 10 OF THEM, BEFORE THE 24 PERIOD WAS UP. PATIENT COULD NOT SAY HOW LONG THEY WERE ON BEFORE THIS HAPPENED. PATIENT WEARS THE V-GO ON HIS ABDOMEN.

  Patient problems: No Information

  MAUDE report 10294701 ↗
• MalfunctionJun 30, 2020Premature Separation; Premature Separation

  THE PATIENT'S MOTHER CALLED TO REPORT THAT HER SON HAS HAD V-GOS DROPPING OFF HIS UPPER ARM AFTER ABOUT SIX HOURS ON AVERAGE. THE REPORTER STATED IT HAPPENED WITH FOUR DEVICES FROM THE SAME BOX AN THIS IS THE FIRST BATCH THIS HAS HAPPENED WITH. THE FIRST ONE WAS ABOUT A WEEK AGO AND TWO CAME OFF YESTERDAY. THE PATIENT'S MOTHER SAID IT MAY BE DUE TO SWEATING, BUT ALSO SHE THINKS IT MAY HAVE BEEN A PROBLEM WITH THE ADHESIVE. SHE SAID THIS HAS NOT HAPPENED BEFORE. THE V-GO'S WERE ALL THROWN OUT.

  Patient problems: No Information

  MAUDE report 10214805 ↗
• MalfunctionJun 23, 2020Premature Separation; Premature Separation

  PATIENT STATED THAT ON FRIDAY AFTER 8 HOURS WITH V-GO ON THE ADHESIVE PAD DID NOT STAY ATTACHED TO HER BODY AND V-GO FELL OFF.

  Patient problems: No Information

  MAUDE report 10186634 ↗
• MalfunctionMar 20, 2020Premature Separation; Premature Separation

  PATIENT REPORTED THAT SHE HAD 2 DEVICES THAT FELL OFF OF HER SKIN AFTER 4 HOURS. THE 1ST TIME IT HAPPENED WAS (B)(6) 2020 AND THE 2ND TIME THE V-GO FELL OFF WAS (B)(6) 2020. PATIENT STATED THAT THERE WAS NO EXCESS MOVEMENT OR SWEATING AT THE TIME OF THE INCIDENTS.

  Patient problems: No Information

  MAUDE report 9859810 ↗

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-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
• 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