AVANOS 13565Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00193494135652), received between Aug 9, 2021 and Aug 9, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2021-00082 FOR THE FIRST REPORT. REFER TO 2026095-2021-00083 FOR THE SECOND REPORT. FILL VOLUME: 143 ML, FLOW RATE: 1 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE 120HR INFUSION OCCURRED FASTER THAN EXPECTED. PER ADDITIONAL INFORMATION RECEIVED 3 AUG 2021 THIS EVENT OCCURRED "DURING THE MONTH OF (B)(6)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297757 ↗
• MalfunctionAug 9, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2021-00082 FOR THE FIRST REPORT. REFER TO 2026095-2021-00084 FOR THE THIRD REPORT. FILL VOLUME: 143 ML, FLOW RATE: 1 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE 120HR INFUSION OCCURRED FASTER THAN EXPECTED, ENDING 36 HOURS BEFORE THE 120 HOUR EXPECTED TIME. PER ADDITIONAL INFORMATION RECEIVED 3 AUG 2021, THE PATIENT WAS SWITCHED TO A 46 HOUR PUMP FOR CONTINUED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293992 ↗
• MalfunctionAug 9, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, NVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2021-00083 FOR THE SECOND REPORT. REFER TO 2026095-2021-00084 FOR THE THIRD REPORT. FILL VOLUME: 143 ML, FLOW RATE: 1 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE 120HR INFUSION OCCURRED FASTER THAN EXPECTED, ENDING 36 HOURS BEFORE THE 120 HOUR EXPECTED TIME. PER ADDITIONAL INFORMATION RECEIVED 3 AUG 2021, THE PATIENT WAS SWITCHED TO A 46 HOUR PUMP FOR CONTINUED THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293516 ↗

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-0585-06 · Jan 17, 2006 · Terminated
  Easypump L T 60-24 infusion pump
• Z-0584-06 · Jan 17, 2006 · Terminated
  Easypump ST 100-1 infusion pump