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Animas Vibe 11651100Recalls & reported problems

Animas Corporation · REV KIT, VIBE PEDS,P2 (OLDER), BLK,mg,US · Class 3

All models of Animas Vibe (45)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Animas Vibe insulin pump has 145 FDA adverse event reports, with no deaths and 6 injuries. Many describe cracked casings or battery compartments, moisture getting in, and blank or incorrect screens. Some mention pumps losing power, and most reports list no consequences for the patient. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
145
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 10840406100341), received between Aug 18, 2016 and Jun 13, 2019 — classified as 6 injuries, 139 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (49 reports).

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 16, 2026.

Most reported problems

Device problems

  • Structural Problem49
  • Moisture Damage23
  • No Display/Image23
  • Electrical /Electronic Property Problem19
  • Device Displays Incorrect Message18
  • Fail-Safe Problem17
  • Failure to Read Input Signal12
  • Image Display Error/Artifact10

Patient problems

  • No Consequences Or Impact To Patient139
  • Hyperglycemia5
  • Polydipsia4
  • Urinary Frequency / Polyuria3
  • Abdominal Pain1
  • Chest Pain1
  • Extreme Exhaustion1
  • Hypoglycemia1

Recent adverse event reports

The 25 most recent of 145 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 13, 2019Image Display Error/Artifact; Moisture Damage; Image Display Error/Artifact; Moisture Damage

    ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. IT WAS ALLEGED THAT THERE WAS MOISTURE BEHIND THE DISPLAY. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY IMPACT THE USER'S ABILITY TO READ SOME OR ALL OF THE INFORMATION ON THE SCREEN WHICH MAY RESULT IN OVER OR UNDER DELIVERY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8695178 ↗
  • MalfunctionMay 17, 2019Structural Problem; Structural Problem

    ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; A CRACKED BATTERY COMPARTMENT. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION CAN RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT OR CARTRIDGE COMPARTMENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8620655 ↗
  • MalfunctionMay 7, 2019Structural Problem; Structural Problem

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE CARTRIDGE COMPARTMENT WAS DAMAGED AND CRACKED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2018.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8587511 ↗
  • MalfunctionApr 25, 2019Structural Problem; Structural Problem

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CASE/CONDITION ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 23-APR-2019.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8548889 ↗
  • MalfunctionMar 28, 2019Structural Problem; Structural Problem

    ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. THE REPORTER ALLEGED THE BATTERY COMPARTMENT WAS CRACKED AND THE YELLOW O-RING OF THE BATTERY CAP WAS VISIBLE WITH THE CAP ON THE PUMP. THE REPORTER DENIED DAMAGE TO THE BATTERY CAP AND DENIED MOISTURE CORROSION IN THE PUMP. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION CAN RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT OR CARTRIDGE COMPARTMENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8460738 ↗
  • MalfunctionFeb 7, 2019Structural Problem; Structural Problem

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A BATTERY COMPARTMENT CRACK. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10-OCT-2018.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8316846 ↗
  • MalfunctionNov 2, 2018Electrical /Electronic Property Problem; Moisture Damage; Electrical /Electronic Property Problem; Moisture Damage

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER STATED THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT OR THE BATTERY CAP. THE YELLOW O-RING ON THE BATTERY CAP WAS CONFIRMED TO NOT BE VISIBLE WHEN THE CAP IS SECURED TO THE PUMP. THE REPORTER STATED THERE WAS MOISTURE CORROSION INSIDE THE BATTERY COMPARTMENT. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8032127 ↗
  • MalfunctionSep 6, 2018Electrical /Electronic Property Problem; Moisture Damage; Structural Problem; Electrical /Electronic Property Problem; Moisture Damage; Structural Problem

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. THE REPORTER ALLEGED THE BATTERY COMPARTMENT WAS CRACKED AND THE PUMP EXPERIENCED AN INTERMITTENT POWER ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7850224 ↗
  • InjuryJul 18, 2018Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 400 MG/DL WITH POLYURIA, POLYDIPSIA, SHORTNESS OF BREATH, STRONG FRUITY BREATH ODOR AND SYMPTOMS OF DEHYDRATION ASSOCIATED WITH AN ALLEGED POWER WITH DAMAGE ISSUE. REPORTEDLY, THE PATIENT DISCONTINUED PUMP THERAPY AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. THE PATIENT DID RECEIVE INSULIN VIA INJECTION. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS NOTED THAT THE BG WAS CONTRIBUTED TO THE POWER INTERRUPTION THAT WAS ASSOCIATED WITH A CRACKED BATTERY COMPARTMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH AN ALLEGED POWER WITH DAMAGE ISSUE.

    Patient problems: Hyperglycemia; Polydipsia; Urinary Frequency / Polyuria

    MAUDE report 7698219 ↗
  • MalfunctionJul 16, 2018Structural Problem; Structural Problem

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS CRACKED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION HAS THE ABILITY TO RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7690889 ↗
  • MalfunctionJul 10, 2018Structural Problem; Structural Problem

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS CRACKED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION HAS THE ABILITY TO RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7674254 ↗
  • MalfunctionJul 6, 2018Moisture Damage; Structural Problem; Moisture Damage; Structural Problem

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE BATTERY COMPARTMENT WAS CRACKED AND MOISTURE WAS PRESENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION HAS THE ABILITY TO RESULT IN A DELAY IN TREATMENT OR LONG-TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT OR CARTRIDGE COMPARTMENT. THERE WAS NO SERIOUS INJURY ASSOCIATED WITH THIS COMPLAINT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7667241 ↗
  • MalfunctionJul 6, 2018Defective Alarm; Defective Alarm

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THERE WAS AN INTERMITTENT VIBRATION ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY CAUSE THE USER TO MISS AN ALARM OR WARNING THAT MAY CAUSE CESSATION OF INSULIN DELIVERY. THERE WAS NO SERIOUS INJURY ASSOCIATED WITH THIS COMPLAINT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7666717 ↗
  • MalfunctionJun 14, 2018Moisture Damage; Failure to Read Input Signal; Moisture Damage; Failure to Read Input Signal

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THE REPORTER ALLEGED MOISTURE WAS BEHIND THE DISPLAY. THE REPORTER ALLEGED THAT THE UP, DOWN, AND OK/ENTER BUTTON'S WERE UNDER RESPONSIVE ON THE KEYPAD. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE HAS THE ABILITY TO RESULT IN INADVERTENT OR INCORRECT INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7602644 ↗
  • MalfunctionJun 5, 2018Defective Alarm; Defective Alarm

    ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS ALARMING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE COULD CAUSE A DELAY IN INSULIN DELIVERY. THERE WAS NO SERIOUS INJURY ASSOCIATED WITH THIS COMPLAINT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7570516 ↗
  • MalfunctionMay 22, 2018Failure to Read Input Signal; Failure to Read Input Signal

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER ALLEGED THAT THE UP, DOWN, AND OK/ENTER BUTTON'S WERE UNDER RESPONSIVE ON THE KEYPAD. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE HAS THE ABILITY TO RESULT IN INADVERTENT OR INCORRECT INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7534444 ↗
  • MalfunctionMay 17, 2018Premature Discharge of Battery; Moisture Damage; Premature Discharge of Battery; Moisture Damage

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ MOISTURE) ISSUE. THE REPORTER ALLEGED THERE WAS MOISTURE IN THE BATTERY COMPARTMENT. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7522930 ↗
  • MalfunctionMay 15, 2018No Display/Image; No Display/Image

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (CLOUDY) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY IMPACT THE USER'S ABILITY TO READ SOME OR ALL OF THE INFORMATION ON THE SCREEN WHICH MAY RESULT IN OVER OR UNDER DELIVERY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7515843 ↗
  • MalfunctionApr 25, 2018Structural Problem; Structural Problem

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. THE CARTRIDGE COMPARTMENT WAS ALLEGED TO BE CRACKED/DAMAGED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION HAS THE ABILITY TO RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE CARTRIDGE COMPARTMENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7458244 ↗
  • MalfunctionApr 21, 2018Structural Problem; Structural Problem

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS ALLEGING A CASING ISSUE. THE REPORTER ALLEGED THAT THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION HAS THE ABILITY TO RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT OR THE CARTRIDGE COMPARTMENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7449684 ↗
  • MalfunctionApr 19, 2018Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. THE REPORTER ALLEGED THE BATTERY CAP WAS UNABLE TO BE REMOVED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7444395 ↗
  • MalfunctionApr 13, 2018Structural Problem; Structural Problem

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. THE BATTERY COMPARTMENT WAS ALLEGED TO BE CRACKED/DAMAGED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION HAS THE ABILITY TO RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7430586 ↗
  • MalfunctionApr 13, 2018Structural Problem; Structural Problem

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. THE CARTRIDGE COMPARTMENT WAS ALLEGED TO BE CRACKED/DAMAGED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION HAS THE ABILITY TO RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE CARTRIDGE COMPARTMENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7430533 ↗
  • MalfunctionApr 4, 2018Structural Problem; Structural Problem

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. THE BATTERY COMPARTMENT WAS ALLEGED TO BE CRACKED/DAMAGED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION HAS THE ABILITY TO RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7397271 ↗
  • InjuryMar 9, 2018Use of Device Problem; Use of Device Problem

    ON 23-FEB-2018, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON (B)(6) 2018, THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF OVER 600 MG/DL, WITH ABDOMINAL PAIN, PAIN IN THE LEGS AND CHEST AND LARGE KETONES, ASSOCIATED WITH AN ALLEGED REMAINING INSULIN READING ISSUE. REPORTEDLY, THE PATIENT REMAINED ON THE PUMP, AND WAS TREATED IN THEIR PHYSICIAN¿S OFFICE WITH INSULIN VIA PUMP, AND INSULIN VIA INJECTION. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THAT THE LOSS OF PRIME WAS TRIGGERED BY AN EMPTY CARTRIDGE ALARM AND WALKED THROUGH COMPLETING REWIND, LOAD, AND PRIME STEPS. THIS COMPLAINT IS BEING REPORTED BECAUSE THERE WAS A BG EXCURSION REQUIRING MEDICAL INTERVENTION ASSOCIATED WITH TRAINING/MISUSE OF THE PUMP.

    Patient problems: Abdominal Pain; Chest Pain; Hyperglycemia

    MAUDE report 7328608 ↗

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