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AVANOS 44273Recalls & reported problems

Avanos Medical, Inc. · HOMEPUMP ECLIPSE* Elastometric Pump · Class 2

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 00193494442736), received between Nov 3, 2020 and Nov 3, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (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

Device problems

  • Excess Flow or Over-Infusion1

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.

  • MalfunctionNov 3, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

    FILL VOLUME: 100ML. FLOW RATE. 50ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE INFUSION DURATION WAS 1 HOUR INSTEAD OF 2 HOURS. PER ADDITIONAL INFORMATION RECEIVED 2020-10-19, THE MEDICATION WAS 25MG KETAMINE + NACL TO A VOLUME OF 100ML. THE PATIENT EXPERIENCED UNUSUAL SUBCUTANEOUS SWELLING AS A RESULT OF THE REPORTED ISSUE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10781334 ↗

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

Other Pump, infusion, elastomeric devices

All Pump, infusion, elastomeric devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.