HyHub Vial Access Device 5500222Recalls & reported problems
Takeda Pharmaceuticals U.S.A., Inc. · The HyHub™ Vial Access Device with four (4) docking stations is a stand-alone, single-use, disposable, non-pyrogenic, gamma sterilized device, which is intended to support the infusion of two medicinal liquids, as prescribed, in a home environment or clinical setting. HyHub is designed to accommodate up to four (4) dual vial units (DVU) to be docked onto the HyHub infusion tray which allows the transfer of medicinal liquids in a needleless, sequential method using standard connections for syringes, applicable pumps, and infusion sets. · Class 2
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 00850025688291), received between Apr 30, 2026 and Apr 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Infuse” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Infuse1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026Failure to Infuse
THE FOLLOWING REPORT WAS RECEIVED IN [email protected]: "CANNOT DRAW IGG FROM IG PORT (VIA PUMP PRIMING AND MANUAL DRAW)".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25053415 ↗
Other Set, I.V. Fluid Transfer devices
- EXACTAMIX H938740Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,350 reports
- EXACTAMIX H938738Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,180 reports
- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 reports
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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