Animas Vibe 11651000Recalls & reported problems
Animas Corporation · REV KIT, VIBE PEDS,P2 (OLDER), BLU,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 is an insulin infusion pump used with a glucose sensor. Most of the 127 reports describe pump malfunctions such as cracked battery compartments, moisture damage, electrical problems, and incorrect on-screen messages, and most say the patient was not affected. The reports include no deaths and 5 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
- 127
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 10840406100334), received between Sep 6, 2016 and Dec 16, 2019 — classified as 5 injuries, 122 malfunctions.
The most frequently reported specific device problem is “Structural Problem” (27 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 Problem27
- Moisture Damage26
- Electrical /Electronic Property Problem22
- Device Displays Incorrect Message21
- Fail-Safe Problem19
- Failure to Read Input Signal12
- Premature Discharge of Battery9
- Image Display Error/Artifact7
Patient problems
- No Consequences Or Impact To Patient122
- Hyperglycemia4
- Hypoglycemia1
Recent adverse event reports
The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2019Structural Problem; Structural Problem
ON (B)(6) 2019, 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 9472711 ↗MalfunctionAug 28, 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 14-AUG-2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8939231 ↗MalfunctionJul 11, 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 08-JUL-2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8779974 ↗MalfunctionApr 22, 2019Premature Discharge of Battery; Premature Discharge of Battery
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. THE REPORTER ALLEGED LESS THAN EXPECTED BATTERY LIFE. THE REPORTER CONFIRMED LOW BATTERY WARNINGS APPEAR IN THE ALARM HISTORY. 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 8536234 ↗MalfunctionMar 13, 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 (B)(6) 2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8416092 ↗MalfunctionDec 11, 2018Electrical /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 ALLEGED A CRACK IN THE BATTERY COMPARTMENT AND REPORTED THE PUMP HAD LOST POWER. THE REPORTER DENIED DAMAGE TO THE BATTERY CAP AND 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 8150267 ↗MalfunctionSep 24, 2018Pumping Problem; Pumping Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE; THE BASAL HISTORY DOES NOT MATCH THE ACTIVE BASAL PROGRAM. THE REPORTER ALLEGED THE BASAL FUNCTION WAS NOT WORKING PROPERLY. 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 7901547 ↗MalfunctionSep 21, 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 7897941 ↗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 DEVICE 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 7854658 ↗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 7843063 ↗MalfunctionAug 27, 2018Pumping Problem; Pumping Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP WAS CONSTANTLY BEEPING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE COULD CAUSE THE PATIENT TO MISS AN ALARM. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7817779 ↗MalfunctionAug 14, 2018No Display/Image; Moisture Damage; No Display/Image; Moisture Damage
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE; MOISTURE 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 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 7782395 ↗MalfunctionAug 3, 2018Failure to Prime; Failure to Prime
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (PRIME ISSUE) ISSUE. THE REPORTER ALLEGED THE PUMP PRIMED OVER 50 UNITS INCORRECTLY DURING THE PRIME SEQUENCE. 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 THE OVER DELIVERY OF INSULIN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7746512 ↗MalfunctionJul 26, 2018Moisture Damage; Moisture Damage
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE. IT WAS ALLEGED THERE WAS MOISTURE BEHIND THE DISPLAY. 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 7721628 ↗MalfunctionJul 18, 2018Electrical /Electronic Property Problem; Moisture Damage; Electrical /Electronic Property Problem; Moisture Damage
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED MOISTURE WAS 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 7698525 ↗MalfunctionJun 28, 2018Electrical /Electronic Property Problem; Moisture Damage; Electrical /Electronic Property Problem; Moisture Damage
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. IT WAS NOTED THAT THERE WAS MOISTURE BEHIND THE DISPLAY. 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 7645078 ↗MalfunctionJun 19, 2018No Display/Image; No Display/Image
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) 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 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 7613577 ↗MalfunctionJun 7, 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 7577675 ↗MalfunctionJun 6, 2018Structural Problem; Structural Problem
ON (B)(6) 2018 THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS ALLEGED THAT THE CARTRIDGE COMPARTMENT WAS CRACKED/DAMAGED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED 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 7572674 ↗MalfunctionMay 21, 2018Moisture Damage; Structural Problem; Moisture Damage; Structural Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CASE DAMAGE W/MOISTURE) ISSUE. THE REPORTER ALLEGED THE BATTERY COMPARTMENT WAS CRACKED, AND MOISTURE WAS PRESENT BEHIND THE DISPLAY. 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 7530669 ↗MalfunctionMay 8, 2018Failure to Sense; Failure to Sense
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. 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 INSULIN OVER DELIVERY IF THE PATIENT IS NOT DISCONNECTED DURING THE LOAD CARTRIDGE STEP. THE OWNER'S BOOKLET PROVIDES A WARNING TO THE USER TO NEVER START THE PRIME/REWIND SEQUENCE ON THE PUMP WHILE THE INFUSION SET IS CONNECTED TO THE BODY AND PROVIDES MULTIPLE REMINDERS DURING THE PRIME/REWIND SEQUENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7495147 ↗MalfunctionApr 25, 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 7459296 ↗MalfunctionFeb 26, 2018Structural Problem; Structural Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE) ISSUE. THE REPORTER ALLEGED THE BATTERY COMPARTMENT CAP WILL NOT ATTACH, AND THERE IS 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 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 7297702 ↗MalfunctionFeb 23, 2018Structural 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 16-FEB-2018.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7293086 ↗MalfunctionFeb 6, 2018Image Display Error/Artifact; Image Display Error/Artifact
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING THE DISPLAY WAS BLANK. 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 7244883 ↗
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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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