Halyard 13560Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10680651135602), received between Jul 10, 2017 and Sep 18, 2019 — classified as 4 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. 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.

• MalfunctionSep 18, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 87 ML, FLOW RATE: 0.5ML/H, PROCEDURE: CHEMOTHERAPY, CATHPLACE: UNKNOWN , INFUSION START TIME: (B)(6) 2019 AT 1740, INFUSION STOP TIME: (B)(6) 2019 AT 1340. IT WAS REPORTED THAT "PATIENT IN HOSPITAL, ON 7 DAY 5FU INFUSION ENDED 20 HOURS EARLIER THAN THE EXPECTED, CAUSED ANXIETY IN PATIENT." NO INJURY REPORTED. PUMP WAS LOCATED OUTSIDE PATIENT CLOTHING OR BLANKET.

  Patient problems: Anxiety

  MAUDE report 9081019 ↗
• MalfunctionApr 19, 2019Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED ONE FAST FLOW EVENT OCCURRED. THERE WAS NO REPORTED INJURY FROM THE FAILURE. THE CLINICIAN REPORTED SHE WAS "NOT SURE ABOUT WHY IT WAS FINISHED EARLY; IT MAY BE THAT NOT ENOUGH MEDICATION WAS ADDED AND IT FINISHED ON TIME. ANYWAY, NO PATIENT INJURY FOR IT." NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8532657 ↗
• MalfunctionJul 10, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2017-00125 FOR THE FIRST EVENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: PERIDURAL, START TIME: (B)(6) 2017 9:20AM, END TIME: (B)(6) 2017 8:00AM. IT WAS REPORTED THAT A PUMP WAS CONNECTED TO A PERIDURAL CATHETER AND WAS SUPPOSED TO RUN FOR FIVE DAYS. HOWEVER, THE INFUSION COMPLETED EARLIER THAN EXPECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6697941 ↗
• MalfunctionJul 10, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2017-00126 FOR THE SECOND EVENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN , PROCEDURE: UNKNOWN, CATHPLACE: PERIDURAL, START TIME: (B)(6) 2017 8:50AM, END TIME: (B)(6) 2017 9:20PM. IT WAS REPORTED THAT A PUMP WAS CONNECTED TO A PERIDURAL CATHETER AND WAS SUPPOSED TO RUN FOR FIVE DAYS. HOWEVER, THE INFUSION COMPLETED EARLIER THAN EXPECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6697939 ↗

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