Animas Vibe 11851500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10840406100617), received between Sep 15, 2016 and Jun 26, 2018 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (3 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2018Pumping Problem; Pumping Problem

  ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT HAD EXPERIENCED A HYPERGLYCEMIC EVENT WHILE ON THE PUMP. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 600 MG/DL WITH SYMPTOMS OF EXTREME THIRST. THE PATIENT WAS TREATED WITH AN INSULIN SHOT TO BRING THEIR BLOOD GLUCOSE DOWN. THE REPORTER WAS UNABLE TO COMPLETE TROUBLESHOOTING AT THE TIME OF THE EVENT. THE REPORTER DID SAY THAT THE SITE WAS CHANGED AND THE BLOOD GLUCOSE DID NOT COME DOWN. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE ON THE PUMP AND THE PUMP COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR.

  Patient problems: Hyperglycemia

  MAUDE report 7637317 ↗
• MalfunctionFeb 26, 2018Premature Discharge of Battery; Structural Problem; Premature Discharge of Battery; Structural Problem

  ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ DAMAGE) ISSUE. THE REPORTER ALLEGED THE BATTERY COMPARTMENT WAS CRACKED, AND WAS RECEIVING FREQUENT LOW BATTERY WARNINGS. 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 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 7296287 ↗
• MalfunctionFeb 26, 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 7296254 ↗
• MalfunctionSep 29, 2017Failure to Prime; Failure to Prime

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS STATING THAT THE PATIENT¿S BG (BLOOD GLUCOSE) WILL GO INTO THE HIGH 200¿S MG/DL AND WILL DROP BETWEEN THE 140¿S-160 MG/DL WITH SYMPTOMS OF DEHYDRATION ASSOCIATED WITH AN ALLEGED PRIME ISSUE. REPORTEDLY THE PATIENT RESUMED PUMP THERAPY AFTER IT WAS REPLACED. THE PATIENT RECEIVED A LOW DOSE OF INSULIN VIA INJECTION AND THE PATIENT¿S MOTHER SPOKE WITH THEIR HEALTH CARE PROVIDER OVER THE PHONE. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS NOTED THAT THE PUMP IS ON THE PRIME/REWIND SCREEN, THE BOXES NEXT TO THE PRIME AND FILL CANNULA WERE NOT SHADED IN BUT THE PUMP WAS NOT ALARMING ¿LOSS OF PRIME.¿ THE REPORTED BG EXCURSION DOES NOT MEET THE CRITERIA OF A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER DOES NOT RECEIVE AN ALARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6904050 ↗
• MalfunctionAug 4, 2017Structural Problem; Structural Problem

  ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (DAMAGED CAP AND CASE)- UNABLE TO REMOVE BATTERY CAP ISSUE. THERE WAS NO INDICATION THE PRODUCT 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 6769610 ↗
• MalfunctionSep 15, 2016Failure to Prime; Failure to Prime

  ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. REPORTEDLY, THE PUMP EMITTED MULTIPLE LOSS OF PRIME WARNINGS WITH MULTIPLE CARTRIDGES. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED AS 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 5953524 ↗