AVANOS 13557Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00193494135577), received between Dec 15, 2020 and Oct 7, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 48 ML. FLOW RATE: 2ML/H. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED "THE ADMINISTRATION OF THE INFUSION WAS PERFORMED SIX HOURS EARLIER THAN SCHEDULED." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 19-SEP-2022 STATED "THE INFUSER WAS PREPARED AND APPARENTLY THEY DID NOT FOLLOW THE CAPACITY INSTRUCTIONS (THEY GAUGED AT 48 ML, AS IF THE INFUSION RATE WERE LINEAR); INFORMATION INDICATES THAT FOR A 60ML INFUSER, IF YOU WANT IT TO BE INFUSED IN 24 HOURS, IT MUST BE CALIBRATED AT 51ML."

  Patient problems: Insufficient Information

  MAUDE report 15567695 ↗
• MalfunctionDec 15, 2020Excess 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 2026095-2020-00182 FOR THE FIRST REPORT ; REFER TO 2026095-2020-00183 FOR THE SECOND REPORT. IT WAS REPORTED THAT, "SEVERAL PUMPS EMPTIED TOO QUICKLY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11010746 ↗
• MalfunctionDec 15, 2020Excess 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 2026095-2020-00182 FOR THE FIRST REPORT ; REFER TO 2026095-2020-00184 FOR THE THIRD REPORT . IT WAS REPORTED THAT ,"SEVERAL PUMPS EMPTIED TOO QUICKLY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11010675 ↗
• MalfunctionDec 15, 2020Excess 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 FIRST OF THREE REPORTS. REFER TO 2026095-2020-00183 FOR THE SECOND REPORT; REFER TO 2026095-2020-00184 FOR THE THIRD REPORT. IT WAS REPORTED THAT, "SEVERAL PUMPS EMPTIED TOO QUICKLY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11010653 ↗

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