Animas Vibe 11551100Recalls & reported problems

Summary

The FDA's MAUDE database contains 636 adverse event reports that list this exact device (DI 10840406100242), received between Aug 8, 2016 and Jun 2, 2020 — classified as 43 injuries, 592 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (199 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

Recent adverse event reports

The 25 most recent of 636 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionDec 27, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2019, 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 9527064 ↗
• MalfunctionOct 21, 2019Structural Problem; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED MULTIPLE CRACKS ON THE BATTERY COMPARTMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 24-SEP-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9213196 ↗
• MalfunctionOct 11, 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 9180436 ↗
• MalfunctionAug 15, 2019Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON 07-AUG-2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 078) ISSUE. IT WAS ALLEGED THAT A CALL SERVICE ALARM [078] 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 8898025 ↗
• MalfunctionAug 15, 2019Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem

  ON 07-AUG-2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 064) ISSUE. IT WAS ALLEGED THAT A 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 8898021 ↗
• MalfunctionAug 13, 2019Structural Problem; Structural Problem

  THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED MULTIPLE CRACKS IN THE BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 05-AUG-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8888110 ↗
• MalfunctionAug 5, 2019Premature Discharge of Battery; Premature Discharge of Battery

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ DAMAGE) ISSUE. IT WAS ALLEGED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THERE WAS AN INTERMITTENT BATTERY LIFE. 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 8859153 ↗
• MalfunctionJul 11, 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. THE REPORTER ALLEGED A CRACKED BATTERY COMPARTMENT, DENIED DAMAGE TO THE BATTERY CAP AND STATED THE BATTERY CAP WILL NOT SECURE TO THE PUMP RESULTING IN A POWER ISSUE. 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 8779973 ↗
• MalfunctionJul 11, 2019Premature Discharge of Battery; Moisture Damage; Premature Discharge of Battery; Moisture Damage

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ MOISTURE) ISSUE; LESS THAN EXPECTED BATTERY LIFE WITH MOISTURE BEHIND THE DISPLAY LENS. 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 8779923 ↗
• MalfunctionMay 19, 2019Structural Problem; Structural Problem

  ON (B)(6) 2019, THE REPORTER ALLEGED THAT THERE WAS A CASING ISSUE. THE REPORTER ALLEGED THAT THE BATTERY AND CARTRIDGE COMPARTMENTS WERE FOUND TO BE CRACKED. THERE WAS NO ALLEGED MOISTURE NOTED IN THE PUMP AND THERE WAS NO ALLEGED DAMAGE TO THE BATTERY CAP. 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 8622655 ↗
• MalfunctionMay 16, 2019No Display/Image; Structural Problem; No Display/Image; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THE DISPLAY SCREEN WAS CRACKED. THE REPORTER CONFIRMED THE SCREEN COULD BE READ SAFELY. 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 8615429 ↗
• MalfunctionApr 3, 2019Structural Problem; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE; A CRACKED BATTERY COMPARTMENT AND 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 8478811 ↗
• MalfunctionMar 21, 2019Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. THE REPORTER STATED THE SCREEN WAS NOT ABLE TO BE READ SAFELY. 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 8439386 ↗
• MalfunctionMar 6, 2019Premature Discharge of Battery; Moisture Damage; Structural Problem; Premature Discharge of Battery; Moisture Damage; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THE PUMP EXPERIENCED LESS THAN EXPECTED BATTERY LIFE AND A CRACK IN THE BATTERY COMPARTMENT. THE REPORTER ALSO STATED THAT THERE WAS MOISTURE INSIDE THE BATTERY COMPARTMENT. THE REPORTER DENIED DAMAGE TO THE BATTERY CAP. 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 8395616 ↗
• MalfunctionMar 1, 2019Structural Problem; Structural Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE) ISSUE. THE REPORTER ALLEGED THE BATTERY COMPARTMENT WAS CRACKED AND THE BATTERY CAP WAS NOT ABLE TO SECURE PROPERLY TO THE PUMP. 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 8381545 ↗
• MalfunctionFeb 12, 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 8330908 ↗
• MalfunctionFeb 7, 2019Structural 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 25-SEP-2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8318088 ↗
• 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 19-DEC-2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8317128 ↗
• MalfunctionFeb 7, 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 15-NOV-2018

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8317001 ↗
• 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 11-DEC-2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8316999 ↗
• MalfunctionFeb 6, 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-JAN-2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8312330 ↗
• InjuryJan 17, 2019Use of Device Problem; Use of Device Problem

  ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 50MG/DL, WITH UNSTEADINESS WITH STANDING AND WALKING, AND A BLOOD GLUCOSE OF 350MG/DL, WITH NAUSEA, ASSOCIATED WITH AN ALLEGED INACCURATE DELIVERY ISSUE. REPORTEDLY, THE PATIENT REMAINED ON THE PUMP, AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS REVEALED THE BASAL DELIVERY TOTALS IN TOTAL DAILY DOSE DID NOT MATCH DUE TO AN ACCESSED BASAL EDIT, AND PRIME MENU. CHANGES WERE ALSO MADE TO THE PUMP BASAL PROGRAM. THE BASAL HISTORY MATCHED THE ACTIVE BASAL PROGRAM SETTINGS. THE BOLUS TOTALS MATCHED, AND ALL BOLUSES WERE RECORDED AS PROGRAMMED. THE PATIENT ALLEGED THE PUMP WAS NOT DELIVERING AS IT WAS SUPPOSED TO. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA AND HYPOGLYCEMIA ASSOCIATED WITH USE ERROR OF THE PUMP.

  Patient problems: Ambulation or Postural Difficulties; Hyperglycemia; Hypoglycemia

  MAUDE report 8258433 ↗
• MalfunctionDec 5, 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 REPORTED ALLEGED THE PUMP HAD NO POWER, THE BATTERY COMPARTMENT WAS CRACKED WITH MOISTURE IN THE BATTERY COMPARTMENT. THE REPORTER DENIED DAMAGE TO THE BATTERY CAP AND STATED THE BATTERY CAP HAD NOT BE REPLACED ON THIS PUMP IN THE LAST 13 MONTHS. 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 8132533 ↗