Animas Vibe 11520200Recalls & reported problems
Animas Corporation · REP KIT, VIBE, ADULT, SIL,mg,US · Class 3
All models of Animas Vibe (45)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Animas Vibe insulin pump delivers insulin to the body. Its 420 reports mostly describe malfunctions such as unresponsive or overly sensitive buttons, a dim or blank screen, cracked casings, and moisture damage. The reports include no deaths and 29 injuries. 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
- 420
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 420 adverse event reports that list this exact device (DI 10840406100211), received between Aug 8, 2016 and May 1, 2020 — classified as 29 injuries, 389 malfunctions.
The most frequently reported specific device problem is “Structural Problem” (150 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 18, 2026.
Most reported problems
Device problems
- Structural Problem150
- Moisture Damage67
- Electrical /Electronic Property Problem58
- Image Display Error/Artifact45
- Device Displays Incorrect Message36
- Fail-Safe Problem35
- Failure to Read Input Signal33
- No Display/Image28
Patient problems
- No Consequences Or Impact To Patient389
- Hypoglycemia17
- Hyperglycemia13
- Polydipsia7
- Confusion/ Disorientation5
- Ambulation or Postural Difficulties4
- Dizziness3
- Blurred Vision2
Recent adverse event reports
The 25 most recent of 420 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2020Failure to Read Input Signal; Failure to Read Input Signal
ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE OK/ENTER BUTTON WAS OVER-RESPONSIVE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS 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 10018317 ↗MalfunctionMay 31, 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 8659240 ↗MalfunctionApr 26, 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 8556007 ↗MalfunctionApr 17, 2019Failure to Read Input Signal; Failure to Read Input Signal
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (ABB TACTILE CNG/UNRESPONSIVE) ISSUE. THE REPORTER ALLEGED THE AUDIO BOLUS BUTTON WAS UNRESPONSIVE. THE REPORTER DENIED MOISTURE IN THE PUMP AND DENIED DAMAGE TO THE AUDIO BOLUS BUTTON COVER. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE CAN RESULT IN INADVERTENT OR INCORRECT BOLUSES WHICH MAY RESULT IN OVER OR UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8522432 ↗MalfunctionApr 17, 2019Failure to Read Input Signal; Failure to Read Input Signal
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE; THE REPORTER ALLEGED THE OK BUTTON WAS OVER RESPONSIVE AND THE REMAINDER OF THE KEYPAD BUTTONS WERE UNRESPONSIVE. THE REPORTER DENIED DAMAGE TO THE KEYPAD AND DENIED MOISTURE 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 ISSUE CAN RESULT IN INADVERTENT OR INCORRECT INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8522431 ↗MalfunctionApr 17, 2019No Display/Image; No Display/Image
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DISPLAY ISSUE) ISSUE; THE REPORTER ALLEGED THE DISPLAY SCREEN GETS DIM AND GOES BLANK FASTER THAN NORMAL. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE 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 THE INFORMATION ON THE SCREEN WHICH MAY RESULT IN OVER OR UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8522429 ↗MalfunctionApr 17, 2019Defective Alarm; Defective Alarm
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A AUDIO TONE/VIBRATION (VIBRATION ISSUE) ISSUE; THE PUMP WAS ALLEGEDLY EXPERIENCING CONTINUAL VIBRATION WITHOUT A KNOWN CAUSE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8522398 ↗MalfunctionFeb 25, 2019Failure to Read Input Signal; Structural Problem; Failure to Read Input Signal; Structural Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGE PRIOR TO DAMAGE) ISSUE. IT WAS REPORTED THAT ALL OF THE KEYPAD BUTTONS WERE UNDER RESPONSIVE; IT WAS NOTED THAT THE KEYPAD WAS TORN. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS 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 8365882 ↗MalfunctionFeb 11, 2019No Display/Image; No Display/Image
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN AN INABILITY TO USE THE PRODUCT WHICH MAY LEAD TO LONG TERM CESSATION OF DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8326972 ↗MalfunctionFeb 7, 2019Structural Problem; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE BATTERY COMPARTMENT WAS CRACKED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 05-NOV-2018.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8318195 ↗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 28-NOV-2018
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8317124 ↗MalfunctionJan 25, 2019Premature Discharge of Battery; Premature Discharge of Battery
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THE PUMP WAS EXPERIENCING AN ISSUE WITH SHORT BATTERY LIFE. THE REPORTER STATED THE PUMP HAD THIS ISSUE ALSO IN (B)(6) 2018 BUT THE ISSUE RECTIFIED ON ITS OWN AT THAT TIME. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. ANIMAS CUSTOMER SUPPORT MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION AND TO PERFORM TROUBLESHOOTING OF THE DEVICE; HOWEVER, THE REPORTER DID NOT RESPOND TO THE FOLLOW-UP ATTEMPTS. IF ADDITIONAL INFORMATION IS RECEIVED, THIS COMPLAINT WILL UPDATED ACCORDINGLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A 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 8277174 ↗MalfunctionJan 21, 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 02-JAN-2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8263814 ↗MalfunctionJan 11, 2019Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. THE REPORTER ALLEGED INTERMITTENT POWER WITH A CRACK IN THE BATTERY COMPARTMENT. THE REPORTER DENIED DAMAGE TO THE BATTERY CAP OR MOISTURE 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 USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8239927 ↗MalfunctionJan 2, 2019Image Display Error/Artifact; Image Display Error/Artifact
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE 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 THE INFORMATION ON THE SCREEN WHICH MAY RESULT IN OVER OR UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8209151 ↗MalfunctionJan 2, 2019Electrical /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 STATED THE PUMP HAD AN INTERMITTENT POWER ISSUE AND THE BATTERY COMPARTMENT WAS CRACKED. THE REPORTER DENIED DAMAGE T THE BATTERY CAP AND STATED THE CAP HAD NEVER BEEN REPLACED ON THE PUMP. 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 8209093 ↗MalfunctionDec 28, 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 WITH MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED THE PUMP WAS WORN WHILE SWIMMING AND AFTERWARD, THE DISPLAY SCREEN HAD GONE BLANK AND THERE WAS WATER IN THE BATTERY COMPARTMENT NOTED WHEN THE BATTERY WAS REMOVED. THE DISPLAY SCREEN REPORTEDLY ILLUMINATED FOR A SHORT TIME WHEN THE BATTERY WAS REPLACED IN THE PUMP, BUT THEN WENT BLANK AGAIN. THE REPORTER ALSO STATED THE KEYPAD BUTTONS WERE UNRESPONSIVE. THE REPORTER STATED THERE WAS A CRACK IN 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 8203636 ↗MalfunctionDec 16, 2018Structural Problem; Structural Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED 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 8168004 ↗MalfunctionDec 6, 2018Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem
ON (B)(4) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. IT WAS REPORTED THAT THE PUMP HAD INTERMITTENT POWER AND A CRACK 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 USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8136807 ↗MalfunctionNov 2, 2018Structural Problem; Structural Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; 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 8032085 ↗MalfunctionOct 12, 2018Structural Problem; Structural Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE) ISSUE. IT WAS ALLEGED THAT THE BATTERY CAP WOULD NOT ATTACH AND THAT THE BATTERY COMPARTMENT WAS SPLIT. 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 7960607 ↗MalfunctionSep 14, 2018No Display/Image; Structural Problem; No Display/Image; Structural Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DAMAGED) ISSUE. IT WAS REPORTED THAT THE DISPLAY SCREEN WAS CRACKED. 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 7876481 ↗MalfunctionSep 13, 2018Structural Problem; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 04-SEP-2018.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7873182 ↗MalfunctionAug 31, 2018Image Display Error/Artifact; Image Display Error/Artifact
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (LINE THROUGH DISPLAY) 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 7840453 ↗MalfunctionAug 31, 2018Structural Problem; Structural Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; CRACKED BATTERY COMPARTMENT. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND INVESTIGATION COMPLETED 23-AUG-2018. ON INVESTIGATION, THE BATTERY COMPARTMENT WAS CONFIRMED TO BE CRACKED. INVESTIGATION DUPLICATED THE COMPLAINT. 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 7836672 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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