Animas Vibe 11451100Recalls & reported problems
Animas Corporation · Insulin Pump Replacement, Adult Black · Class 3
All models of Animas Vibe (45)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Animas Vibe is an insulin pump used to deliver insulin. Its 2,262 reports often describe cracked or damaged casings, moisture, a dim or faded screen, and incorrect messages, and mention 39 injuries and 2 deaths. Most reports note no impact on the patient. 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
- 2,262
- Deaths reported
- 2
- Injuries reported
- 39
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,262 adverse event reports that list this exact device (DI 10840406100051), received between Aug 8, 2016 and Sep 14, 2020 — classified as 2 deaths, 39 injuries, 2,216 malfunctions.
The most frequently reported specific device problem is “Structural Problem” (1,155 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 18, 2026.
Most reported problems
Device problems
- Structural Problem1,155
- Device Displays Incorrect Message333
- Fail-Safe Problem329
- Electrical /Electronic Property Problem300
- Moisture Damage298
- Image Display Error/Artifact195
- Failure to Read Input Signal142
- Premature Discharge of Battery108
Patient problems
- No Consequences Or Impact To Patient2,212
- Hyperglycemia27
- Hypoglycemia12
- Elevated Ketones/ Diabetic Ketoacidosis7
- Nausea6
- Polydipsia5
- Urinary Frequency / Polyuria4
- Vomiting4
Recent adverse event reports
The 25 most recent of 2,262 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2020Fail-Safe Problem; Fail-Safe Problem
ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 052/053/054/055 SLEEP) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10528191 ↗MalfunctionSep 14, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A NO POWER 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 POWER ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10527928 ↗MalfunctionSep 11, 2020Structural Problem; Structural Problem
ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. IT WAS ALLEGED 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 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 10523319 ↗MalfunctionSep 10, 2020Electrical /Electronic Property Problem; Moisture Damage; Electrical /Electronic Property Problem; Moisture Damage
ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED INTERMITTENT POWER ISSUE. IN ADDITION, IT WAS REPORTED THAT THERE WAS MOISTURE BEHIND THE DISPLAY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10515108 ↗MalfunctionAug 28, 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 22-AUG-2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8939375 ↗MalfunctionAug 27, 2019Failure to Read Input Signal; Failure to Read Input Signal
THE PUMP WAS RETURNED FOR INVESTIGATION. THE KEYPAD COVER WAS OPENED AND THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL OF THE KEYPAD BUTTON CONTACTS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 16-AUG-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 8936192 ↗MalfunctionAug 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 (B)(6) 2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8854586 ↗MalfunctionJul 24, 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 8821891 ↗MalfunctionJul 24, 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 THAT COULD NOT BE CLEARED FROM THE PUMP. 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 8821860 ↗MalfunctionJul 24, 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 078) ISSUE THAT COULD NOT BE CLEARED FROM THE PUMP. 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 8821858 ↗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 8790054 ↗MalfunctionJul 9, 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 8771104 ↗MalfunctionJul 2, 2019Image Display Error/Artifact; Failure to Read Input Signal; Structural Problem; Image Display Error/Artifact; Failure to Read Input Signal; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A KEYPAD/BUTTON ISSUE, A DISPLAY ISSUE AND A CASE/CONDITION ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 01-JUL-2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8752866 ↗MalfunctionJun 13, 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 11-JUN-2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8695681 ↗MalfunctionJun 3, 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; CS 069 ALARM. 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 8663494 ↗MalfunctionMay 21, 2019Retraction Problem; Retraction Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THE PUMP WOULD NOT PERFORM THE REWIND STEP AND THE PISTON ROD INSIDE THE CARTRIDGE COMPARTMENT WAS NOT RETRACTING. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. NO FURTHER INFORMATION WAS AVAILABLE. ANIMAS CUSTOMER SUPPORT MADE SEVERAL ATTEMPTS TO FOLLOW-UP WITH THE REPORTER TO PERFORM TROUBLESHOOTING OF THE ISSUE; HOWEVER, THE REPORTER DID NOT RESPOND TO THE FOLLOW-UP ATTEMPTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE INSULIN DELIVERY COULD BE AFFECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8627114 ↗MalfunctionMay 21, 2019No Audible Alarm; No Audible Alarm
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THE PUMP DID NOT HAVE AUDIBLE ALARM SOUNDS WHEN THE PUMP GIVES AN ALARM. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. NO FURTHER INFORMATION WAS AVAILABLE. ANIMAS CUSTOMER SUPPORT MADE SEVERAL ATTEMPTS TO CONTACT THE REPORT TO COMPLETE TROUBLESHOOTING OF THE ALLEGED ISSUE; HOWEVER THE REPORTER DID NOT RESPOND TO FOLLOW-UP ATTEMPTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE 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 8627105 ↗MalfunctionMay 20, 2019Structural Problem; Structural Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE) ISSUE. THE BATTERY COMPARTMENT IS REPORTEDLY CRACKED AND THE THREADS ON THE BATTERY CAP 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 8623604 ↗MalfunctionMay 16, 2019Electrical /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 PUMP HAS NO POWER. THE REPORTER ALLEGED A CRACK IN THE BATTERY COMPARTMENT. THE REPORTER ALLEGED THE BATTERY CAP WOULD NOT SECURE PROPERLY TO THE PUMP AND DENIED DAMAGE TO THE BATTERY CAP. THE REPORTER STATED IT HAD BEEN MORE THAN 13 MONTHS SINCE THE BATTERY CAP HAD BEEN REPLACED ON THIS PUMP. THE REPORTER DENIED MOISTURE IN THE PUMP. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE REPORTER DECLINED TO RETURN THE PUMP TO ANIMAS, STATING THEY WOULD DESTROY THE PUMP THEMSELVES. 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 8615395 ↗MalfunctionMay 15, 2019Image Display Error/Artifact; Failure to Read Input Signal; Structural Problem; Image Display Error/Artifact; Failure to Read Input Signal; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED A DIM, DISCOLORED DISPLAY. EVALUATION ALSO REVEALED MULTIPLE CRACKS IN THE BATTERY COMPARTMENT. ALL OF THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND CONTAMINATION WAS FOUND UNDER ALL BUTTON CONTACTS. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 13-MAY-2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8611389 ↗MalfunctionMay 14, 2019Structural Problem; Structural Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; A CRACKED CARTRIDGE COMPARTMENT. THE CARTRIDGE CAP IS ALLEGEDLY NOT ABLE TO SECURE TO THE 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 8607866 ↗MalfunctionMay 14, 2019Device Displays Incorrect Message; Communication or Transmission Problem; Fail-Safe Problem; Device Displays Incorrect Message; Communication or Transmission Problem; Fail-Safe Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (COMMUNICATION) 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 8607748 ↗MalfunctionMay 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. IT WAS ALLEGED THAT THE BATTERY COMPARTMENT WAS DAMAGED AND THERE WAS AN ALLEGED 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 8602496 ↗MalfunctionApr 23, 2019Structural Problem; Structural Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. THE REPORTER ALLEGED THE CARTRIDGE COMPARTMENT WAS CRACKED AND THE THREADS IN THE CARTRIDGE COMPARTMENT WERE STRIPPED. THE REPORTER DENIED DAMAGE TO THE CARTRIDGE CAP AND FURTHER DENIED MOISTURE IN THE PUMP. 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 8539283 ↗MalfunctionApr 3, 2019Image Display Error/Artifact; Structural Problem; Image Display Error/Artifact; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CASE/CONDITION ISSUE, A KEYPAD BUTTON ISSUE AND A DISPLAY ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8479067 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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