Halyard 13565Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10680651135657), received between Mar 15, 2019 and May 15, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionMay 15, 2020Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 270 ML, FLOW RATE: 1 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT "THE PUMP HAS RUN EMPTY TOO QUICKLY. THE PUMP HAD ALREADY RUN OUT AFTER TWO DAYS. FILLING VOLUME WAS 270 ML ALL ACCORDING TO THE INSTRUCTIONS." NO PATIENT INJURY WAS REPORTED. THE PUMP WAS FILLED WITH 5FU [FLUOROURACIL].

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10062105 ↗
• MalfunctionMar 15, 2019Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2019-00045 FOR THE SECOND EVENT. REFER TO 2026095-2019-00046 FOR THE THIRD EVENT. FILL VOLUME: 178 ML 113.1ML DILUENT/74.9ML DRUG, FLOW RATE: 1 ML/HR, PROCEDURE: CHEMOTHERAPY DELIVERY, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP INFUSED 48-HOURS TO 50-HOURS TOO FAST. THERE WAS NO REPORTED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8424225 ↗
• MalfunctionMar 15, 2019Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2019-00044 FOR THE FIRST EVENT. REFER TO 2026095-2019-00046 FOR THE THIRD EVENT. FILL VOLUME: 178 ML 113.1ML DILUENT/74.9ML DRUG, FLOW RATE: 1 ML/HR, PROCEDURE: CHEMOTHERAPY DELIVERY, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP INFUSED 48-HOURS TO 50-HOURS TOO FAST. THERE WAS NO REPORTED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8424223 ↗
• MalfunctionMar 15, 2019Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2019-00044 FOR THE FIRST EVENT. REFER TO 2026095-2019-00045 FOR THE SECOND EVENT. FILL VOLUME: 178 ML 113.1ML DILUENT/74.9ML DRUG, FLOW RATE: 1 ML/HR, PROCEDURE: CHEMOTHERAPY DELIVERY, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP INFUSED 48-HOURS TO 50-HOURS TOO FAST. THERE WAS NO REPORTED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8424222 ↗

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