enFlow™ 980121EURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752125803), received between Jun 23, 2022 and Jun 23, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K130867); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2022Human-Device Interface Problem; Human-Device Interface Problem

  THE CLINICAL RESEARCH ASSOCIATE, MEDICAL AFFAIRS CONSUMABLES OF VYAIRE MEDICAL REPORTED THAT THERE WAS AN ADVERSE EVENT REPORTED DURING THE ENFLOW PMCF CLINICAL STUDY. AT THE END OF THE SURGERY, IT WAS OBSERVED THAT AFTER CHANGING THE FLUID TO SODIUM CHLORIDE, THE PATIENTS VEIN HAD RUPTURED. THE VEIN DAMAGE WAS ASSESSED TO BE CAUSED BY POOR CANNULA PLACEMENT OR THE PATIENT'S VEIN COULD NOT WITHSTAND THE PRESSURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14795270 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130867. One submission often covers many models, so check the product and lot details in each record.

• Z-1386-2019 · Mar 13, 2019 · Terminated
  enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
• Z-1385-2019 · Mar 13, 2019 · Terminated
  enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.