Animas Vibe 11520100Recalls & reported problems
Animas Corporation · REP KIT, VIBE, ADULT, 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 appears in 873 adverse event reports, with 19 injuries and no deaths. Many describe cracked battery or cartridge compartments, moisture getting in, and power loss, with some mentioning incorrect messages and time or date resets. Most list no impact on the patient, though some mention high or low blood sugar. 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
- 873
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 873 adverse event reports that list this exact device (DI 10840406100204), received between Aug 9, 2016 and Feb 20, 2020 — classified as 19 injuries, 853 malfunctions.
The most frequently reported specific device problem is “Structural Problem” (343 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 Problem343
- Moisture Damage165
- Electrical /Electronic Property Problem114
- Device Displays Incorrect Message81
- Fail-Safe Problem81
- Failure to Read Input Signal77
- Image Display Error/Artifact76
- No Display/Image68
Patient problems
- No Consequences Or Impact To Patient852
- Hyperglycemia15
- Hypoglycemia6
- Lethargy3
- Polydipsia3
- Confusion/ Disorientation2
- Elevated Ketones/ Diabetic Ketoacidosis2
- Nausea2
Recent adverse event reports
The 25 most recent of 873 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2020Date/Time-Related Software Problem; Date/Time-Related Software Problem
ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS ALLEGING A TIME/DATE RESET ISSUE. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THIS COMPLAINT. CUSTOMER SUPPORT HAS MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW UP, HOWEVER, THE REPORTER DID NOT RESPOND. NO FURTHER INFORMATION WAS AVAILABLE; IF FURTHER INFORMATION IS PROVIDED A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION OF A TIME/DATE ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9732344 ↗MalfunctionFeb 19, 2020Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem
ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS ALLEGING A POWER (DAMAGE) ISSUE. IT WAS REPORTED THAT THE BATTERY CAP WAS UNABLE TO PROPERLY SECURE TO THE PUMP AND THAT THE PUMP HAD NO POWER. IT WAS ALSO REPORTED 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 USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9728950 ↗MalfunctionOct 22, 2019Structural Problem; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE BATTERY COMPARTMENT WAS CRACKED AND THE KEYPAD WAS PEELING THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2019. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9217906 ↗MalfunctionAug 2, 2019Date/Time-Related Software Problem; Date/Time-Related Software 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 (B)(6) 2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8855917 ↗MalfunctionMay 7, 2019Structural Problem; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED A CRACK IN THE CARTRIDGE COMPARTMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 26-OCT-2018.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8587376 ↗MalfunctionApr 25, 2019Premature Discharge of Battery; Premature Discharge of Battery
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. THE REPORTER CONFIRMED LOW BATTERY WARNINGS IN THE ALARM HISTORY OF THE PUMP. THE REPORTER DENIED DAMAGE TO THE PUMP AND THE BATTERY CAP. THE REPORTER DENIED MOISTURE IN THE PUMP. THE REPORTER STATED THAT RECHARGEABLE BATTERIES HAVE BEEN BEING USED IN THE PUMP AFTER THE PUMP BEGAN HAVING ISSUES WITH SHORT BATTERY LIFE USING CONVENTIONAL BATTERIES. PER OWNERS BOOKLET: OPTIMUM BATTERY LIFE WITH (B)(6) LITHIUM L91 AA BATTERY. SHOULD NOT USE RECHARGEABLE OR CARBON-ZINC BATTERIES. 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 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 8548869 ↗MalfunctionApr 12, 2019No Display/Image; No Display/Image
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. THE REPORTER ALLEGED THE DISPLAY SCREEN WENT BLANK AND THERE WAS MOISTURE IN THE BATTERY COMPARTMENT. CUSTOMER TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING AND DETERMINED THE BLANK DISPLAY SCREEN ISSUE WAS NOT RELATED TO A POWER 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 8510609 ↗MalfunctionApr 12, 2019Electrical /Electronic Property Problem; Moisture Damage; Electrical /Electronic Property Problem; Moisture Damage
ON (B)(6) -2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED THERE WAS MOISTURE IN THE BATTERY COMPARTMENT AND NO POWER TO THE PUMP. THE REPORTER DENIED DAMAGE TO THE PUMP AND BATTERY CAP. THE REPORTER STATED THE ISSUE BEGAN AS AN INTERMITTENT POWER ISSUE AND PROGRESSED TO A NO POWER ISSUE A FEW DAYS LATER. 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 8510322 ↗MalfunctionApr 10, 2019Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 064) 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 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 8500528 ↗MalfunctionApr 10, 2019Premature Discharge of Battery; Moisture Damage; Premature Discharge of Battery; Moisture Damage
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ MOISTURE) ISSUE. THE REPORTER ALLEGED MOISTURE IN THE BATTERY COMPARTMENT, DENIED DAMAGE TO THE PUMP AND BATTERY CAP. 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 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 8500527 ↗MalfunctionApr 9, 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 UNDER RESPONSIVE WHICH WAS PREVENTING THE PUMP FROM MOVING PAST THE VERIFY SCREEN. 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 8495523 ↗MalfunctionApr 3, 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 8478762 ↗MalfunctionMar 27, 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 STATED THE PUMP HAD NO POWER, THE BATTERY COMPARTMENT WAS CRACKED, THERE WAS NO DAMAGE TO THE BATTERY CAP BUT THE YELLOW O-RING ON THE CAP WAS VISIBLE AND THE CAP WOULD NOT SECURE TIGHTLY TO THE PUMP. THE REPORTER STATED THE BATTERY CAP HAD NEVER BEEN REPLACED ON THIS 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 8455687 ↗MalfunctionMar 7, 2019Structural Problem; Structural Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; A DAMAGED CARTRIDGE 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 8398513 ↗MalfunctionFeb 26, 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 BATTERY COMPARTMENT WAS CRACKED AND THE PUMP WAS EXPERIENCING INTERMITTENT POWER LOSS. THE CONDITION OF THE BATTERY CAP IS UNKNOWN. IT IS ALSO UNKNOWN WHEN THE BATTERY CAP WAS LAST 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 8369948 ↗MalfunctionFeb 12, 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 THAT THE PUMP WAS EXPERIENCING AN INTERMITTENT POWER ISSUE. THE REPORTER STATED THE BATTERY COMPARTMENT WAS CRACKED, WHICH WAS PREVIOUSLY REPORTED ON MEDWATCH REPORT # 2531779-2019-01175, AND NOW STATES THE DAMAGE TO THE BATTERY COMPARTMENT HAS WORSENED AND THE BATTERY CAP IS NOT ABLE TO SECURE PROPERLY TO THE PUMP AND THE PUMP EXPERIENCES INTERMITTENT POWER OUTAGE. THE REPORTER DENIED DAMAGE TO THE BATTERY CAP AND STATED THE BATTERY CAP HAD NOT BEEN REPLACED IN MORE THAN 13 MONTHS. 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 8331095 ↗MalfunctionFeb 12, 2019Structural Problem; Structural Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; A DAMAGED CARTRIDGE 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 8330940 ↗MalfunctionFeb 12, 2019Structural Problem; Structural Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; A CRACKED CARTRIDGE 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 8330753 ↗MalfunctionFeb 7, 2019Structural Problem; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 03-JAN-2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8316996 ↗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 05-NOV-2018.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8316949 ↗MalfunctionFeb 6, 2019Structural Problem; Structural Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; THE REPORTER ALLEGED 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 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 8309756 ↗MalfunctionFeb 6, 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 8309721 ↗MalfunctionJan 31, 2019Image Display Error/Artifact; Structural Problem; Image Display Error/Artifact; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED CONTAMINATION UNDER THE KEYPAD, A BATTERY COMPARTMENT CRACK AND A DIM/FADING COLOR SPECTRUM. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 24-JAN-2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8292179 ↗MalfunctionJan 25, 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 AN INTERMITTENT POWER ISSUE BECAUSE THE BATTERY CAP IS NOT ABLE TO BE SECURED PROPERLY TO THE PUMP AND THE BATTERY COMPARTMENT IS CRACKED. THE REPORTER DENIED THAT THERE WAS 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 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 8277976 ↗MalfunctionJan 22, 2019Structural Problem; Structural Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. THE REPORTER ALLEGED THAT THE CARTRIDGE COMPARTMENT WAS CRACKED AND THE THREADS STRIPPED. 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 8266484 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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