Animas Vibe 11451200Recalls & reported problems
Animas Corporation · Insulin Pump Replacement, Adult Silver · 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 is the subject of 1,064 adverse event reports, which mention no deaths and 30 injuries. Most reports describe malfunctions such as keypad buttons that become unresponsive or peel, screens that dim or are hard to read, and cracks in the battery compartment. Some reports mention blood sugar running too high or too low. 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
- 1,064
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,064 adverse event reports that list this exact device (DI 10840406100082), received between Aug 6, 2016 and Dec 27, 2019 — classified as 30 injuries, 1,028 malfunctions.
The most frequently reported specific device problem is “Structural Problem” (505 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 Problem505
- Device Displays Incorrect Message165
- Fail-Safe Problem161
- Electrical /Electronic Property Problem134
- Moisture Damage113
- Image Display Error/Artifact87
- Failure to Read Input Signal70
- Premature Discharge of Battery49
Patient problems
- No Consequences Or Impact To Patient1,023
- Hyperglycemia27
- Hypoglycemia12
- Nausea7
- Confusion/ Disorientation6
- Polydipsia6
- Lethargy3
- Urinary Frequency / Polyuria3
Recent adverse event reports
The 25 most recent of 1,064 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 27, 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 THE OK KEYPAD BUTTON WAS UNDER RESPONSIVE AND THE KEYPAD WAS PEELING. 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 9526600 ↗MalfunctionJun 19, 2019Structural Problem; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED A CRACK IN THE BATTERY COMPARTMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 14-JUN-2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8711402 ↗MalfunctionJun 17, 2019Image Display Error/Artifact; Image Display Error/Artifact
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISPLAY ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06/14/2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8705003 ↗MalfunctionApr 26, 2019Image Display Error/Artifact; Image Display Error/Artifact
ON (B)(6) 2019, 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 8556091 ↗MalfunctionApr 26, 2019No Display/Image; Structural Problem; No Display/Image; Structural Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DAMAGED) ISSUE. THE REPORTER STATED THE SCREEN IS NOT ABLE TO BE READ SAFELY. 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 8556042 ↗MalfunctionApr 9, 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 (B)(6) 2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8496124 ↗MalfunctionApr 2, 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 THE PUMP HAD INTERMITTENT POWER LOSS, THE BATTERY COMPARTMENT WAS CRACKED AND THE BATTERY CAP COULD NOT SECURE PROPERLY TO THE PUMP. THE REPORTER CONFIRMED THE YELLOW O-RING ON THE BATTERY CAP WAS VISIBLE WHEN THE CAP IS ON THE PUMP. THE REPORTER DENIED THAT THERE WAS DAMAGE TO THE BATTERY CAP AND DENIED MOISTURE IN THE PUMP. THE REPORTER STATED THE BATTERY CAP HAD BEEN REPLACED ON THIS PUMP FOUR-TO-SIX MONTHS AGO. 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 8472772 ↗MalfunctionMar 20, 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; ALL KEYPAD BUTTON ARE ALLEGEDLY UNDER RESPONSIVE. 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 8436971 ↗MalfunctionFeb 12, 2019Image Display Error/Artifact; Image Display Error/Artifact
ON (B)(6) 2019, 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 8331687 ↗MalfunctionFeb 12, 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 8330944 ↗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 22-OCT-2018.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8318144 ↗MalfunctionFeb 7, 2019Structural Problem; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CASE/CONDITION. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 17-OCT-2018.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8317362 ↗MalfunctionFeb 7, 2019Structural Problem; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED MULTIPLE CRACKS IN THE BATTERY COMPARTMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 04-FEB-2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8314814 ↗MalfunctionJan 23, 2019Image Display Error/Artifact; Image Display Error/Artifact
ON (B)(6) 2019, 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 8270856 ↗MalfunctionJan 23, 2019Structural Problem; Structural Problem
ON (B)(6) 2019, 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 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 8270706 ↗MalfunctionJan 18, 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 A CRACK IN THE BATTERY COMPARTMENT. THE REPORTER DENIED DAMAGE TO THE BATTERY CAP. 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 8261882 ↗MalfunctionJan 18, 2019Image Display Error/Artifact; Image Display Error/Artifact
ON (B)(6) 2019, 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 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 8261614 ↗MalfunctionJan 11, 2019No Display/Image; No Display/Image
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. THE REPORTER STATED THE PUMP HAD BEEN DROPPED AND THE SCREEN REMAINS BLANK AFTERWARD. THE REPORTER CONFIRMED THERE WAS POWER TO THE PUMP AS THE PUMP CHIRPS AND VIBRATES ON STARTUP. 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 8239620 ↗MalfunctionJan 3, 2019Structural Problem; Structural Problem
THE REPORTER CONTACTED ANIMAS ON (B)(6) 2019 ALLEGING THE BATTERY COMPARTMENT AND THE CARTRIDGE COMPARTMENT WERE BOTH CRACKED. 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 8214368 ↗InjuryNov 14, 2018Device Sensing Problem; Device Sensing Problem
THE REPORTER CONTACTED ANIMAS ON (B)(6) 2018 ALLEGING THE PATIENT EXPERIENCED HYPOGLYCEMIA WHILE ON INSULIN PUMP THERAPY EVIDENCED BY BLOOD GLUCOSE MEASURING 48 MG/DL WITH CONFUSION AND LIGHTHEADEDNESS. THE PATIENT REPORTEDLY DID NOT RECEIVE ANY TREATMENT ABOVE OR BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. THE REPORTER ALLEGED A HISTORY/SETTINGS ISSUE WITH THE PUMP; THE BASAL HISTORY REPORTEDLY DOES NOT MATCH THE ACTIVE BASAL PROGRAM. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY ASSOCIATED WITH A HISTORY/SETTINGS ISSUE.
Patient problems: Confusion/ Disorientation; Hypoglycemia
MAUDE report 8070521 ↗MalfunctionNov 7, 2018Low Audible Alarm; Low Audible Alarm
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING QUIET SOUNDS ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED 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 8045682 ↗MalfunctionNov 7, 2018Pumping Problem; Pumping Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE; THE REPORTER STATED THAT THE PUMP IS NOT PROVIDING AN ALARM WHEN THE PATIENT'S BLOOD GLUCOSE IS LOW. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE IS BEING REPORTED AS AN ISSUE WITH THE PUMP NOT PERFORMING AS INTENDED WITH REGARDS TO THE HISTORY OR THE SETTINGS MAY RESULT IN OVER OR UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8045446 ↗MalfunctionNov 6, 2018Pumping Problem; Pumping Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER ALLEGED THE PUMP BOLUS HISTORY SHOWS DELIVERIES THAT THE PATIENT KNOWS THEY DID NOT MAKE ON (B)(6) 2018, (B)(6) 2018, (B)(6) 2018 AND (B)(6) 2018. THE REPORTER STATED THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA IN EARLY AUGUST WITH BLOOD GLUCOSE MEASURING 44 MG/DL WITH ARM WEAKNESS. THIS COMBINATION OF BLOOD GLUCOSE LEVEL AND SYMPTOM DOES NOT MEET ANIMAS' CRITERIA FOR A REPORTABLE ADVERSE EVENT. NO ADVERSE EVENT IS BEING REPORTED IN ASSOCIATION WITH THIS COMPLAINT. THE PUMP'S BOLUS TOTALS DO NOT MATCH WHAT WAS PROGRAMMED BY A >5% DIFFERENCE. THIS ISSUE IS BEING REPORTED AS AN ISSUE WITH THE PUMP NOT PERFORMING AS INTENDED WITH REGARDS TO THE HISTORY OR THE SETTINGS MAY RESULT IN OVER OR UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8043592 ↗MalfunctionOct 26, 2018Image Display Error/Artifact; Structural Problem; Image Display Error/Artifact; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE PUMP HAD A DIM DISPLAY WITH A PINK HUE. INVESTIGATION REVEALED THE BATTERY COMPARTMENT WAS CRACKED FROM THE TOP ABOVE THE PAD TO THE COVER PART. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 11-OCT-2018.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8009077 ↗MalfunctionOct 18, 2018Structural Problem; Structural Problem
ON (B)(6) 2018, 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7979223 ↗
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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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