LifeFlow Rapid Infusion System FG5001Recalls & reported problems
410 Medical Innovation, LLC · Rapid Infusion system including handle and sterile tubing set SA5101 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B355FG50011), received between Jul 28, 2017 and Jul 28, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Embolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2017Insufficient Device Problem Information
PATIENT NOTED TO HAVE MODERATE AMOUNT OF AIR IN RIGHT ATRIUM, RIGHT VENTRICLE, INTERNAL MAMMARY REGION, AS WELL AS A MILD AMOUNT OF AIR ALONG ANTERIOR RIGHT CHEST AND NECK WITH CTA. LIFEFLOW MANUAL RAPID INFUSER USED TO INFUSE FLUIDS ALONG WITH PRESSURE BAG AND TUBING FOR RAPID INFUSION OF 1 LITER OF SALINE, IV PUMP FOR INFUSION OF NOREPINEPHRINE AND A CT CONTRAST INFUSER.
Patient problems: Embolism
MAUDE report 6750397 ↗
Other Set, Administration, Intravascular devices
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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