Animas Vibe 11551200Recalls & reported problems
Animas Corporation · REV KIT, VIBE, ADULT, SIL, 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 worn on the body to deliver insulin continuously. Its 191 reports mostly describe malfunctions, such as cracked or moisture-damaged housings, dim or blank screens, and incorrect messages on the display. Most reports say the device had no effect on the patient, though some mention high blood sugar. There are 13 injury reports and no deaths. 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
- 191
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 191 adverse event reports that list this exact device (DI 10840406100259), received between Aug 10, 2016 and Jun 8, 2020 — classified as 13 injuries, 178 malfunctions.
The most frequently reported specific device problem is “Structural Problem” (49 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 Problem49
- Moisture Damage28
- Image Display Error/Artifact24
- Electrical /Electronic Property Problem23
- Device Displays Incorrect Message19
- Fail-Safe Problem18
- Failure to Read Input Signal15
- No Display/Image13
Patient problems
- No Consequences Or Impact To Patient177
- Hyperglycemia11
- Nausea3
- Fatigue2
- Polydipsia2
- Urinary Frequency / Polyuria2
- Abdominal Pain1
- Dizziness1
Recent adverse event reports
The 25 most recent of 191 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2020Image Display Error/Artifact; Image Display Error/Artifact
ON (B)(6) 2020, 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 10129334 ↗MalfunctionJul 23, 2019No Display/Image; Moisture Damage; No Display/Image; Moisture Damage
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. IT WAS ALLEGED THAT THE 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 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 8815711 ↗MalfunctionJul 11, 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 8779982 ↗MalfunctionJun 12, 2019Image Display Error/Artifact; Image Display Error/Artifact
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM/FADING SCREEN. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06-JUN-2019
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8691049 ↗MalfunctionApr 9, 2019Moisture Damage; Failure to Read Input Signal; Moisture Damage; Failure to Read Input Signal
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THE REPORTER ALLEGED MOISTURE BEHIND THE DISPLAY AND ALL THE KEYPAD BUTTONS BEING UNDER RESPONSIVE. THE REPORTER DENIED DAMAGE TO THE KEYPAD COVER. 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 8494982 ↗MalfunctionApr 9, 2019Moisture Damage; Structural Problem; Moisture Damage; Structural Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CASE DAMAGE W/MOISTURE) ISSUE; A CRACKED BATTERY COMPARTMENT WITH MOISTURE. 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 8494954 ↗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 05-NOV-2018.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8317131 ↗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 20-SEP-2018.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8317046 ↗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 CARTRIDGE COMPARTMENT. THE REPORTER DENIED DAMAGE TO THE CARTRIDGE 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 8309818 ↗MalfunctionJan 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 8219112 ↗MalfunctionOct 18, 2018No Display/Image; No Display/Image
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. THE SCREEN IS REPORTEDLY INTERMITTENTLY BLANK. 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 7979428 ↗MalfunctionOct 18, 2018Structural Problem; Structural Problem
ON (B)(6) 2018, 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 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 7979225 ↗MalfunctionSep 28, 2018Inaccurate Delivery; Inaccurate Delivery
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (DB MGT INACCURATE DELIVERY) ISSUE. IT WAS ALLEGED THE PUMP HAD AN INACCURATE DELIVERY ISSUE. THE REPORTER WAS NOT ABLE TO PROVIDE FURTHER INFORMATION DURING THE INITIAL COMPLAINT. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THERE WAS 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 7919235 ↗MalfunctionSep 21, 2018Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem
ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT THERE WAS A CALL SERVICE 064 ALARM. 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. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7898519 ↗MalfunctionSep 7, 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 [064] 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 7855338 ↗MalfunctionAug 30, 2018Structural Problem; Structural Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED ISSUE. IT WAS REPORTED THAT THE CARTRIDGE AND BATTERY COMPARTMENTS WERE 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 OR CARTRIDGE COMPARTMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7834890 ↗MalfunctionAug 30, 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 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 7834453 ↗MalfunctionAug 13, 2018No Display/Image; Structural Problem; No Display/Image; Structural Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DAMAGED) ISSUE. IT WAS REPORTED THAT THE DISPLAY SCREEN WAS SCRATCHED AND UNABLE TO BE READ SAFELY. 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 7779799 ↗MalfunctionAug 3, 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. IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THAT THE CAP WOULD NOT REMAIN TIGHTENED TO THE PUMP. 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 7746252 ↗MalfunctionAug 3, 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. IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THAT THE CAP WOULD NOT REMAIN TIGHTENED TO THE PUMP. 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 7746228 ↗MalfunctionJul 30, 2018Inaccurate Delivery; Inaccurate Delivery
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING AN INACCURATE DELIVERY EVENT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE LEVEL OF 400 MG/DL, WITHOUT ANY OTHER SYMPTOMS OF HYPERGLYCEMIA. THIS INCIDENT DOES NOT MEET ANIMAS'S DEFINITION OF AN ADVERSE EVENT. 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 THERE IS AN ALLEGATION AGAINST THE DELIVERY FUNCTION OF THE PUMP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7730420 ↗MalfunctionJul 30, 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 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 7730416 ↗MalfunctionJul 27, 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. IT WAS NOTED THAT THERE WAS MOISTURE IN THE DISPLAY AND 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 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 7725658 ↗MalfunctionJul 26, 2018Image Display Error/Artifact; Image Display Error/Artifact
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (SEGMENTS MISSING) ISSUE. IT WAS REPORTED THAT THE PUMP SCREEN IS BLACKED OUT ON THE LEFT SIDE OF THE SCREEN. 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 7721641 ↗MalfunctionJul 6, 2018Electrical /Electronic Property Problem; Moisture Damage; Structural Problem; Electrical /Electronic Property Problem; Moisture Damage; Structural Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE WITH MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED THE BATTERY COMPARTMENT WAS CRACKED WITH MOISTURE PRESENT. 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 7667271 ↗
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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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