Animas VibeRecalls & reported problems across all models
Animas Corporation · 45 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11,129
- Deaths reported
- 4
- Injuries reported
- 475
- Recalls
- 0
We found 45 models of Animas Vibe by Animas Corporation in the FDA's device registry (GUDID). Together they are named in 11,129 adverse event reports in the FDA's MAUDE database, received between Aug 6, 2016 and Sep 14, 2020 — classified as 4 deaths, 475 injuries, 10,631 malfunctions.
The most frequently reported specific device problem is “Structural Problem” (4,388 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Animas Vibe problems
Device problems
- Structural Problem4,388
- Moisture Damage1,575
- Device Displays Incorrect Message1,479
- Electrical /Electronic Property Problem1,458
- Fail-Safe Problem1,433
- Image Display Error/Artifact921
- Failure to Read Input Signal896
- No Display/Image640
Patient problems
- No Consequences Or Impact To Patient10,608
- Hyperglycemia349
- Hypoglycemia136
- Nausea75
- Polydipsia73
- Vomiting47
- Confusion/ Disorientation40
- Urinary Frequency / Polyuria36
Animas Vibe models
45 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Animas Vibe 11451100Pump, infusion, insulin, to be used with invasive glucose sensor2 deaths2,262 reports
- Animas Vibe 11451000Pump, infusion, insulin, to be used with invasive glucose sensor1,122 reports
- Animas Vibe 11451200Pump, infusion, insulin, to be used with invasive glucose sensor1,064 reports
- Animas Vibe 11520100Pump, infusion, insulin, to be used with invasive glucose sensor873 reports
- Animas Vibe 11451400Pump, infusion, insulin, to be used with invasive glucose sensor784 reports
- Animas Vibe 11551100Pump, infusion, insulin, to be used with invasive glucose sensor636 reports
- Animas Vibe 11451500Pump, infusion, insulin, to be used with invasive glucose sensor516 reports
- Animas Vibe 11520000Pump, infusion, insulin, to be used with invasive glucose sensor472 reports
- Animas Vibe 11520200Pump, infusion, insulin, to be used with invasive glucose sensor420 reports
- Animas Vibe 13920000Pump, infusion, insulin, to be used with invasive glucose sensor294 reports
- Animas Vibe 11420100Pump, infusion, insulin, to be used with invasive glucose sensor213 reports
- Animas Vibe 11520400Pump, infusion, insulin, to be used with invasive glucose sensor209 reports
- Animas Vibe 11520500Pump, infusion, insulin, to be used with invasive glucose sensor206 reports
- Animas Vibe 11551000Pump, infusion, insulin, to be used with invasive glucose sensor198 reports
- Animas Vibe 11551200Pump, infusion, insulin, to be used with invasive glucose sensor191 reports
- Animas Vibe 11651100Pump, infusion, insulin, to be used with invasive glucose sensor145 reports
- Animas Vibe 11420200Pump, infusion, insulin, to be used with invasive glucose sensor144 reports
- Animas Vibe 11551400Pump, infusion, insulin, to be used with invasive glucose sensor131 reports
- Animas Vibe 13920000Pump, infusion, insulin, to be used with invasive glucose sensor1 death129 reports
- Animas Vibe 11651000Pump, infusion, insulin, to be used with invasive glucose sensor127 reports
- Animas Vibe 13920000Pump, infusion, insulin, to be used with invasive glucose sensor123 reports
- Animas Vibe 11420400Pump, infusion, insulin, to be used with invasive glucose sensor119 reports
- Animas Vibe 11420000Pump, infusion, insulin, to be used with invasive glucose sensor107 reports
- Animas Vibe 11551500Pump, infusion, insulin, to be used with invasive glucose sensor92 reports
- Animas Vibe 13920000Pump, infusion, insulin, to be used with invasive glucose sensor75 reports
- Animas Vibe 11651500Pump, infusion, insulin, to be used with invasive glucose sensor70 reports
- Animas Vibe 11420500Pump, infusion, insulin, to be used with invasive glucose sensor60 reports
- Animas Vibe 13920000Pump, infusion, insulin, to be used with invasive glucose sensor1 death51 reports
- Animas Vibe 11651400Pump, infusion, insulin, to be used with invasive glucose sensor48 reports
- Animas Vibe 11651200Pump, infusion, insulin, to be used with invasive glucose sensor47 reports
- Animas Vibe 11620000Pump, infusion, insulin, to be used with invasive glucose sensor46 reports
- Animas Vibe 11620100Pump, infusion, insulin, to be used with invasive glucose sensor46 reports
- Animas Vibe 11851400Pump, infusion, insulin, to be used with invasive glucose sensor22 reports
- Animas Vibe 11620400Pump, infusion, insulin, to be used with invasive glucose sensor21 reports
- Animas Vibe 11620500Pump, infusion, insulin, to be used with invasive glucose sensor20 reports
- Animas Vibe 11851000Pump, infusion, insulin, to be used with invasive glucose sensor13 reports
- Animas Vibe 11620200Pump, infusion, insulin, to be used with invasive glucose sensor11 reports
- Animas Vibe 11851500Pump, infusion, insulin, to be used with invasive glucose sensor6 reports
- Animas Vibe 11820000Pump, infusion, insulin, to be used with invasive glucose sensor5 reports
- Animas Vibe 11820400Pump, infusion, insulin, to be used with invasive glucose sensor3 reports
- Animas Vibe 11851200Pump, infusion, insulin, to be used with invasive glucose sensor3 reports
- Animas Vibe 11851100Pump, infusion, insulin, to be used with invasive glucose sensor2 reports
- Animas Vibe 11820100Pump, infusion, insulin, to be used with invasive glucose sensor1 report
- Animas Vibe 11820200Pump, infusion, insulin, to be used with invasive glucose sensor1 report
- Animas Vibe 11820500Pump, infusion, insulin, to be used with invasive glucose sensor1 report
Recent Animas Vibe adverse event reports
The 15 most recent reports across all models, 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, 2020Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem
ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CALL SERVICE ALARM ISSUE) ISSUE. IT WAS NOTED THAT THE PUMP EMITTED A CS 069 SERVICE ALARM. 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 10528171 ↗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 ↗MalfunctionJul 28, 2020Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem
ON (B)(6) 2020, 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 10334831 ↗MalfunctionJul 14, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2020, 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 10273120 ↗MalfunctionJul 14, 2020Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem
ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. IT WAS REPORTED THAT THE PUMP HAD INTERMITTENT POWER AND 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 10273105 ↗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 ↗MalfunctionJun 2, 2020Premature Discharge of Battery; Structural Problem; Premature Discharge of Battery; Structural Problem
ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ DAMAGE) ISSUE. IT WAS ALLEGED THAT THE BATTERY COMPARTMENT WAS CRACKED. 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 10108564 ↗MalfunctionMay 1, 2020Failure to Read Input Signal; Failure to Read Input Signal
ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE OK/ENTER BUTTON WAS OVER-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 10018317 ↗MalfunctionApr 22, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS ALLEGING A POWER (NO 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 9985818 ↗InjuryMar 31, 2020Pumping Problem; Pumping Problem
ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE ¿PUMP HE (PATIENT) LOST BUT THE PUMP MALFUNCTIONED AND CAUSED HIM TO BE HOSPITALIZED¿. CUSTOMER TECHNICAL SUPPORT (CTS) WAS UNABLE TO DETERMINE WHAT THE ISSUES WERE WITH THE PUMP. TROUBLESHOOTING COULD NOT BE COMPLETED AT THE TIME OF THE COMPLAINT. CTS MADE ATTEMPTS TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION AND TROUBLESHOOTING, WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED DUE TO ISSUES WITH THE PUMP. THE PUMP COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR.
Patient problems: No Code Available
MAUDE report 9903272 ↗MalfunctionMar 4, 2020Image Display Error/Artifact; Image Display Error/Artifact
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM/PINK DISPLAY. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 27-FEB-2020. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9785232 ↗MalfunctionFeb 20, 2020Date/Time-Related Software Problem; Date/Time-Related Software Problem
ON (B)(6) 2020, THE REPORTER CONTACTED ANIMAS ALLEGING A TIME/DATE RESET 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 TIME/DATE ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9732344 ↗
Other Animas Corporation products
All Animas Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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