Animas Vibe 11451000Recalls & reported problems
Animas Corporation · Insulin Pump Replacement, Adult Blue · 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 delivers insulin. Of its 1,122 reports, 33 describe injuries and 1,089 describe malfunctions, with no deaths. Many reports describe cracked battery compartments, dim or fading displays, and unresponsive buttons. Some say these issues could affect reading the screen or using the pump. The latest report is from October 2019. 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
- 1,122
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,122 adverse event reports that list this exact device (DI 10840406100044), received between Aug 8, 2016 and Oct 22, 2019 — classified as 33 injuries, 1,089 malfunctions.
The most frequently reported specific device problem is “Structural Problem” (506 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 Problem506
- Device Displays Incorrect Message183
- Fail-Safe Problem178
- Moisture Damage145
- Electrical /Electronic Property Problem134
- Image Display Error/Artifact98
- Failure to Read Input Signal94
- No Display/Image53
Patient problems
- No Consequences Or Impact To Patient1,088
- Hyperglycemia19
- Hypoglycemia11
- Nausea7
- Blurred Vision4
- Vomiting4
- Headache3
- Abdominal Pain2
Recent adverse event reports
The 25 most recent of 1,122 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 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 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 9217727 ↗MalfunctionOct 18, 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. IT WAS REPORTED THAT THE OK/ENTER BUTTON WAS UNDER-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 9211220 ↗MalfunctionSep 6, 2019Image Display Error/Artifact; Image Display Error/Artifact
ON 29-AUG-2019, THE REPORTER CONTACTED ANIMAS ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. CUSTOMER TECHNICAL SUPPORT WAS UNABLE TO COMPLETE TROUBLESHOOTING AT THE TIME OF THE CALL. FURTHER ATTEMPTS TO CONTACT THE REPORTER WERE UNSUCCESSFUL. 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 8968839 ↗MalfunctionJul 15, 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 12-JUL-2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8790036 ↗MalfunctionJul 2, 2019Image Display Error/Artifact; Structural Problem; Image Display Error/Artifact; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A BATTERY COMPARTMENT CRACK AND A DIM/FADING COLOR SPECTRUM. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 01-JUL-2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8753014 ↗MalfunctionJun 4, 2019Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THE PUMP EMITTED A CALL SERVICE ALARM. HOWEVER, THE REPORTER STATED THEY DID NOT KNOW WHAT CALL SERVICE ALARM WAS EMITTED. ANIMAS CUSTOMER SUPPORT MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW-UP FOR ADDITIONAL INFORMATION; HOWEVER, THE REPORTER DID NOT RESPOND. 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 8666856 ↗MalfunctionMay 23, 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 ALLEGED THE DISPLAY LENS WAS SCRATCHED AND THE DISPLAY COULD NOT 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 8635657 ↗MalfunctionMay 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 8635656 ↗MalfunctionMay 23, 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, A CRACKED BATTERY COMPARTMENT AND THE BATTERY CAP DOES NOT SECURE PROPERLY TO THE PUMP. THE REPORTER CONFIRMED THE YELLOW O-RING OF THE BATTERY CAP WAS VISIBLE WHEN ON THE PUMP. THE REPORTER DENIED DAMAGE TO THE BATTERY CAP AND STATED IT HAD BEEN REPLACED 7-12 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 8635631 ↗MalfunctionMay 20, 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 8623684 ↗MalfunctionMay 20, 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 (CALL SERVICE ALARM ISSUE) ISSUE; CALL SERVICE ALARM 069 OCCURRED WHEN THE PUMP WAS DROPPED ON THE FLOOR. 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 8623574 ↗MalfunctionMay 16, 2019Image Display Error/Artifact; Image Display Error/Artifact
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. THE REPORTER DECLINED TO PARTICIPATE IN TROUBLESHOOTING ACTIVITIES WITH ANIMAS CUSTOMER SUPPORT. 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 8615507 ↗MalfunctionMay 16, 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 BATTERY CAP YELLOW O-RING WAS VISIBLE WHEN ON THE PUMP, THE THREADS OF THE BATTERY COMPARTMENT WERE STRIPPED, THE BATTERY CAP WAS NOT DAMAGED BUT DOES NOT SECURE TO THE PUMP, THE BATTERY CAP HAS NEVER BEEN REPLACED ON THIS PUMP AND THE PUMP HAS INTERMITTENT POWER ISSUES. THE REPORTER STATED THAT THEY ARE SECURING THE BATTERY CAP TO THE PUMP USING DUCT TAPE. THE REPORTER WAS ADVISED AGAINST THIS PRACTICE BY ANIMAS CUSTOMER SUPPORT. 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 8615368 ↗MalfunctionMay 12, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING A POWER (INTERMITTENT POWER) ISSUE. 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 8602507 ↗MalfunctionMay 12, 2019Defective Alarm; Defective Alarm
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING AN AUDIO TONE/VIBRATION (VIBRATION ISSUE) ISSUE. IT WAS REPORTED THAT THE PUMP WAS EMITTING A CONSTANT VIBRATION FOR 30 MINUTES WHILE THE PATIENT WAS WEARING IT. 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 8602506 ↗MalfunctionMay 6, 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 8582598 ↗MalfunctionMar 27, 2019Image Display Error/Artifact; Image Display Error/Artifact
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM/FADING COLOR SPECTRUM. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 19-MAR-2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8455638 ↗MalfunctionMar 15, 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 (CALL SERVICE ALARM ISSUE) ISSUE: CALL SERVICE 078 ALARM OCCURRED. 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 8424613 ↗MalfunctionMar 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 AND CLAIMED DIFFICULTY SECURING THE BATTERY CAP TO 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 8395477 ↗MalfunctionMar 4, 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 8386656 ↗MalfunctionJan 30, 2019Premature Discharge of Battery; Structural Problem; Premature Discharge of Battery; Structural Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ DAMAGE) ISSUE. IT WAS REPORTED THAT THE PUMP EMITTED A LOW BATTERY WARNING. IT WAS ALSO NOTED THAT THERE WAS A CRACK IN THE BATTERY COMPARTMENT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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 8288322 ↗MalfunctionDec 20, 2018Structural Problem; Structural Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE BATTERY COMPARTMENT WAS CRACKED. 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 ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8183872 ↗MalfunctionDec 12, 2018Structural Problem; Structural Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE) ISSUE; THE CARTRIDGE COMPARTMENT AND CARTRIDGE CAP ARE BOTH ALLEGEDLY DAMAGED. THE REPORTER STATED THE CARTRIDGE 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 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 8155977 ↗MalfunctionDec 3, 2018Image Display Error/Artifact; Moisture Damage; Structural Problem; Image Display Error/Artifact; Moisture Damage; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED CONTAMINATION UNDER THE KEYPAD BUTTONS, A BATTERY COMPARTMENT CRACK, A DIM/FADED DISPLAY, AND MOISTURE WITHIN THE PUMP. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12-NOV-2018.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8123574 ↗MalfunctionNov 27, 2018Structural Problem; Temperature Problem; Structural Problem; Temperature Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (TEMP - PHYSICAL DAMAGE) ISSUE. IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS DAMAGED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THERE IS THE POTENTIAL FOR THE USER TO EXPERIENCE AN INJURY TO THE SKIN DUE TO INCREASED PUMP TEMPERATURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8105794 ↗
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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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