Animas Vibe 11851100Recalls & reported problems
Animas Corporation · REV KIT, VIBE PEDS P1, BLK,mg,US · Class 3
All models of Animas Vibe (45)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10840406100587), received between Jan 9, 2017 and Aug 31, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Prime” (1 report).
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
- Failure to Prime1
- Moisture Damage1
- No Display/Image1
- Structural Problem1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2017No Display/Image; Moisture Damage; Structural Problem; No Display/Image; Moisture Damage; Structural Problem
ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DAMAGED WITH MOISTURE) ISSUE. THE REPORTER ALLEGED THERE WERE SCRATCHES ON THE DISPLAY AND THEY WERE UNABLE TO READ IT. THERE WAS ALLEGED MOISTURE BEHIND THE DISPLAY. 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 6837065 ↗MalfunctionJan 9, 2017Failure to Prime; Failure to Prime
ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT THE PUMP REPEATEDLY EMITTED LOSS OF PRIME WARNINGS DESPITE CARTRIDGE CHANGES. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE IS BEING REPORTED BECAUSE IT 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 6235776 ↗
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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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