Animas Vibe 11820500Recalls & reported problems
Animas Corporation · REP KIT, VIBE PEDS P1, LGN,mg,US · Class 3
All models of Animas Vibe (45)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10840406100563), received between Aug 12, 2016 and Aug 12, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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
- Electrical /Electronic Property Problem1
- Moisture Damage1
- Structural Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2016Electrical /Electronic Property Problem; Moisture Damage; Structural Problem; Electrical /Electronic Property Problem; Moisture Damage; Structural Problem
ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE WITH MOISTURE INGRESS) ISSUE. IT WAS REPORTED THAT THERE IS AN INTERMITTENT POWER ISSUE. IT WAS ALSO REPORTED THAT THERE IS DAMAGE AND MOISTURE INGRESS TO THE BATTERY COMPARTMENT. 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 5874282 ↗
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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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