AVANOS 34891Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193494348915), received between Jan 24, 2023 and Jan 24, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K052117); 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.

• MalfunctionJan 24, 2023Inaccurate Flow Rate; Inflation Problem; Inaccurate Flow Rate; Inflation Problem

  FILL VOLUME: 100 ML. FLOW RATE: 200 ML. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PUMP INFLATED ON THE SIDE AND THE INFUSION PASSED IN LESS THAN 15 MINUTES. THE PUMP WAS PLACED NEXT TO THE INFUSION SITE. THE PATIENT TOLERATED IT WELL. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16236979 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052117. One submission often covers many models, so check the product and lot details in each record.

• Z-2111-2009 · Feb 11, 2008 · Terminated
  I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico. The Easypump LT is indicated for continuous and/or intermittent infusion of medicatio
• Z-0584-06 · Jan 17, 2006 · Terminated
  Easypump ST 100-1 infusion pump
• Z-0585-06 · Jan 17, 2006 · Terminated
  Easypump L T 60-24 infusion pump