Animas Vibe 11420100Recalls & reported problems
Animas Corporation · Insulin Pump & CGM System, Adult Black · 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 213 adverse event reports, with no deaths and 2 injuries. Reports mention cracked casings, display fading, unresponsive buttons, repeated service alarms and intermittent power loss, and most say the patient had no impact. 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
- 213
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 213 adverse event reports that list this exact device (DI 10840406100099), received between Aug 8, 2016 and Oct 5, 2018 — classified as 2 injuries, 211 malfunctions.
The most frequently reported specific device problem is “Structural Problem” (92 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 Problem92
- Moisture Damage38
- Electrical /Electronic Property Problem36
- Device Displays Incorrect Message35
- Fail-Safe Problem33
- Failure to Read Input Signal20
- No Display/Image14
- Image Display Error/Artifact8
Patient problems
- No Consequences Or Impact To Patient211
- Hyperglycemia1
- Hypoglycemia1
- Nausea1
Recent adverse event reports
The 25 most recent of 213 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 5, 2018Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS AND REPORTED THAT CALL SERVICE ALARM 087 HAD BEEN EMITTED BY THE PUMP MORE OFTEN THAN EXPECTED BY THE USER. 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 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 7938595 ↗MalfunctionSep 7, 2018Image Display Error/Artifact; Image Display Error/Artifact
ON (B)(6) 2018, 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 7854935 ↗MalfunctionSep 4, 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 CARTRIDGE 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 CARTRIDGE COMPARTMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7843524 ↗MalfunctionAug 23, 2018Image Display Error/Artifact; Image Display Error/Artifact
ON (B)(6) 2018, 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 7811920 ↗MalfunctionJul 18, 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 OK/ENTER BUTTON WAS 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 7698753 ↗MalfunctionApr 21, 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 CARTRIDGE 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 7449693 ↗MalfunctionApr 3, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ON (B)(6) 2018, 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 7394171 ↗MalfunctionMar 21, 2018Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 069) ISSUE. 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 7357450 ↗MalfunctionJan 26, 2018Structural Problem; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACKED/DAMAGED BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON THE RESULTS OF THE INVESTIGATION COMPLETED 29-DEC-2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7221197 ↗MalfunctionJan 10, 2018No Display/Image; Moisture Damage; No Display/Image; Moisture Damage
ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE DISPLAY SCREEN WAS BLANK AND THERE WAS MOISTURE IN THE BATTERY COMPARTMENT. THERE WAS NO INDICATION THAT THE DEVICE 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 7178541 ↗MalfunctionJan 10, 2018Moisture Damage; Structural Problem; Moisture Damage; Structural Problem
ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS ALLEGING A CASING/CONDITION (CASE DAMAGE WITH MOISTURE) ISSUE. IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THERE WAS MOISTURE PRESENT IN THE PUMP. THERE IS NO INDICATION THAT THE PRODUCT ISSUE 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 CARTRIDGE COMPARTMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7178356 ↗MalfunctionJan 2, 2018Protective Measures Problem; Protective Measures Problem
ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (SUSPEND) ISSUE.THIS COMPLAINT IS BEING REPORTED BECAUSE SUSPENDING OR RESUMING OF THE PUMP WITHOUT AN ALARM MAY RESULT IN OVER OR UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7156749 ↗MalfunctionDec 22, 2017Image Display Error/Artifact; Image Display Error/Artifact
ON (B)(6) 2017, 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 7143806 ↗MalfunctionNov 13, 2017Structural Problem; Structural Problem
ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS 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 7027077 ↗MalfunctionNov 13, 2017Structural Problem; Structural Problem
ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS 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 7027068 ↗MalfunctionNov 13, 2017Structural Problem; Structural Problem
ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS 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 7027062 ↗MalfunctionNov 1, 2017No Display/Image; Moisture Damage; Structural Problem; No Display/Image; Moisture Damage; Structural Problem
ON (B)(4) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DAMAGED WITH MOISTURE) ISSUE. THE REPORTER ALLEGED THE DISPLAY WAS CRACKED AND THERE WAS MOISTURE. 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 6995444 ↗MalfunctionOct 25, 2017Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem
ON (B)(6), THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) ISSUE. IT WAS REPORTED THAT THERE WAS A 069 CALL SERVICE ALARM. THERE WAS NO INDICATION THAT THIS ISSUE LEAD TO AN ADVERSE EVENT. THIS 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 6978829 ↗MalfunctionOct 20, 2017Structural Problem; Structural Problem
ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE) ISSUE. THE BATTERY COMPARTMENT CAP THREADS WERE ALLEGED TO BE STRIPPED. 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 6965952 ↗MalfunctionOct 19, 2017Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem
ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) ISSUE. IT WAS REPORTED THAT THERE WAS A 069 CALL SERVICE ALARM. THERE WAS NO INDICATION THAT THIS ISSUE LEAD TO AN ADVERSE EVENT. THIS 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 6964073 ↗MalfunctionOct 19, 2017Structural 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 10/02/2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6963983 ↗MalfunctionOct 16, 2017Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem
ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. IT WAS ALLEGED THAT THE BATTERY COMPARTMENT WAS CRACKED WITH INTERMITTENT POWER. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE 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 6953821 ↗MalfunctionOct 9, 2017Moisture Damage; Structural Problem; Moisture Damage; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE BATTERY COMPARTMENT WAS CRACKED AND THERE WAS MOISTURE IN IT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6933557 ↗MalfunctionOct 2, 2017Structural 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 (B)(6) 2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6907185 ↗MalfunctionOct 2, 2017Structural Problem; Structural Problem
ON (B)(6) 2017, 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 6906850 ↗
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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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