Halyard 44280Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10680651442809), received between Sep 18, 2017 and Sep 18, 2017 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE EIGHTH OF TEN REPORTS. REFER TO 2026095-2017-00163 FOR THE FIRST PATIENT. REFER TO 2026095-2017-00164 FOR THE SECOND PATIENT. REFER TO 2026095-2017-00165 FOR THE THIRD PATIENT. REFER TO 2026095-2017-00166 FOR THE FOURTH PATIENT. REFER TO 2026095-2017-00167 FOR THE FIFTH PATIENT. REFER TO 2026095-2017-00168 FOR THE SIXTH PATIENT. REFER TO 2026095-2017-00169 FOR THE SEVENTH PATIENT. REFER TO 2026095-2017-00171 FOR THE NINTH PATIENT. REFER TO 2026095-2017-00172 FOR THE TENTH PATIENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT 10 DEVICES UNDER THE SAME BATCH NUMBER HAD INFUSED FASTER THAN EXPECTED. INSTEAD OF 24 HOURS SCHEDULED INFUSION, THEY COMPLETED IN 12 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6873745 ↗
• MalfunctionSep 18, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE FIFTH OF TEN REPORTS. REFER TO 2026095-2017-00163 FOR THE FIRST PATIENT. REFER TO 2026095-2017-00164 FOR THE SECOND PATIENT. REFER TO 2026095-2017-00165 FOR THE THIRD PATIENT. REFER TO 2026095-2017-00166 FOR THE FOURTH PATIENT. REFER TO 2026095-2017-00168 FOR THE SIXTH PATIENT. REFER TO 2026095-2017-00169 FOR THE SEVENTH PATIENT. REFER TO 2026095-2017-00170 FOR THE EIGHTH PATIENT. REFER TO 2026095-2017-00171 FOR THE NINTH PATIENT. REFER TO 2026095-2017-00172 FOR THE TENTH PATIENT. IT WAS REPORTED THAT 10 DEVICES UNDER THE SAME BATCH NUMBER HAD INFUSED FASTER THAN EXPECTED. INSTEAD OF 24 HOURS SCHEDULED INFUSION, THEY COMPLETED IN 12 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6873741 ↗
• MalfunctionSep 18, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE TENTH OF TEN REPORTS. REFER TO 2026095-2017-00163 FOR THE FIRST PATIENT. REFER TO 2026095-2017-00164 FOR THE SECOND PATIENT. REFER TO 2026095-2017-00165 FOR THE THIRD PATIENT. REFER TO 2026095-2017-00166 FOR THE FOURTH PATIENT. REFER TO 2026095-2017-00167 FOR THE FIFTH PATIENT. REFER TO 2026095-2017-00168 FOR THE SIXTH PATIENT. REFER TO 2026095-2017-00169 FOR THE SEVENTH PATIENT. REFER TO 2026095-2017-00170 FOR THE EIGHTH PATIENT. REFER TO 2026095-2017-00171 FOR THE NINTH PATIENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT 10 DEVICES UNDER THE SAME BATCH NUMBER HAD INFUSED FASTER THAN EXPECTED. INSTEAD OF 24 HOURS SCHEDULED INFUSION, THEY COMPLETED IN 12 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6873738 ↗
• MalfunctionSep 18, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE NINTH OF TEN REPORTS. REFER TO 2026095-2017-00163 FOR THE FIRST PATIENT. REFER TO 2026095-2017-00164 FOR THE SECOND PATIENT. REFER TO 2026095-2017-00165 FOR THE THIRD PATIENT. REFER TO 2026095-2017-00166 FOR THE FOURTH PATIENT. REFER TO 2026095-2017-00167 FOR THE FIFTH PATIENT. REFER TO 2026095-2017-00168 FOR THE SIXTH PATIENT. REFER TO 2026095-2017-00169 FOR THE SEVENTH PATIENT. REFER TO 2026095-2017-00170 FOR THE EIGHTH PATIENT. REFER TO 2026095-2017-00172 FOR THE TENTH PATIENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT 10 DEVICES UNDER THE SAME BATCH NUMBER HAD INFUSED FASTER THAN EXPECTED. INSTEAD OF 24 HOURS SCHEDULED INFUSION, THEY COMPLETED IN 12 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6873733 ↗
• MalfunctionSep 18, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE SIXTH OF TEN REPORTS. REFER TO 2026095-2017-00163 FOR THE FIRST PATIENT. REFER TO 2026095-2017-00164 FOR THE SECOND PATIENT. REFER TO 2026095-2017-00165 FOR THE THIRD PATIENT. REFER TO 2026095-2017-00166 FOR THE FOURTH PATIENT. REFER TO 2026095-2017-00167 FOR THE FIFTH PATIENT. REFER TO 2026095-2017-00169 FOR THE SEVENTH PATIENT. REFER TO 2026095-2017-00170 FOR THE EIGHTH PATIENT. REFER TO 2026095-2017-00171 FOR THE NINTH PATIENT. REFER TO 2026095-2017-00172 FOR THE TENTH PATIENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT 10 DEVICES UNDER THE SAME BATCH NUMBER HAD INFUSED FASTER THAN EXPECTED. INSTEAD OF 24 HOURS SCHEDULED INFUSION, THEY COMPLETED IN 12 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6873729 ↗
• MalfunctionSep 18, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE FIRST OF TEN REPORTS. REFER TO 2026095-2017-00164 FOR THE SECOND PATIENT. REFER TO 2026095-2017-00165 FOR THE THIRD PATIENT. REFER TO 2026095-2017-00166 FOR THE FOURTH PATIENT. REFER TO 2026095-2017-00167 FOR THE FIFTH PATIENT. REFER TO 2026095-2017-00168 FOR THE SIXTH PATIENT. REFER TO 2026095-2017-00169 FOR THE SEVENTH PATIENT. REFER TO 2026095-2017-00170 FOR THE EIGHTH PATIENT. REFER TO 2026095-2017-00171 FOR THE NINTH PATIENT. REFER TO 2026095-2017-00172 FOR THE TENTH PATIENT. IT WAS REPORTED THAT 10 DEVICES UNDER THE SAME BATCH NUMBER HAD INFUSED FASTER THAN EXPECTED. INSTEAD OF 24 HOURS SCHEDULED INFUSION, THEY COMPLETED IN 12 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6873723 ↗
• MalfunctionSep 18, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE SEVENTH OF TEN REPORTS. REFER TO 2026095-2017-00163 FOR THE FIRST PATIENT. REFER TO 2026095-2017-00164 FOR THE SECOND PATIENT. REFER TO 2026095-2017-00165 FOR THE THIRD PATIENT. REFER TO 2026095-2017-00166 FOR THE FOURTH PATIENT. REFER TO 2026095-2017-00167 FOR THE FIFTH PATIENT. REFER TO 2026095-2017-00168 FOR THE SIXTH PATIENT. REFER TO 2026095-2017-00170 FOR THE EIGHTH PATIENT. REFER TO 2026095-2017-00171 FOR THE NINTH PATIENT. REFER TO 2026095-2017-00172 FOR THE TENTH PATIENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THAT 10 DEVICES UNDER THE SAME BATCH NUMBER HAD INFUSED FASTER THAN EXPECTED. INSTEAD OF 24 HOURS SCHEDULED INFUSION, THEY COMPLETED IN 12 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6873720 ↗
• MalfunctionSep 18, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE FOURTH OF TEN REPORTS. REFER TO 2026095-2017-00163 FOR THE FIRST PATIENT. REFER TO 2026095-2017-00164 FOR THE SECOND PATIENT. REFER TO 2026095-2017-00165 FOR THE THIRD PATIENT. REFER TO 2026095-2017-00167 FOR THE FIFTH PATIENT. REFER TO 2026095-2017-00168 FOR THE SIXTH PATIENT. REFER TO 2026095-2017-00169 FOR THE SEVENTH PATIENT. REFER TO 2026095-2017-00170 FOR THE EIGHTH PATIENT. REFER TO 2026095-2017-00171 FOR THE NINTH PATIENT. REFER TO 2026095-2017-00172 FOR THE TENTH PATIENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT 10 DEVICES UNDER THE SAME BATCH NUMBER HAD INFUSED FASTER THAN EXPECTED. INSTEAD OF 24 HOURS SCHEDULED INFUSION, THEY COMPLETED IN 12 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6873716 ↗
• MalfunctionSep 18, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE THIRD OF TEN REPORTS. REFER TO 2026095-2017-00163 FOR THE FIRST PATIENT. REFER TO 2026095-2017-00164 FOR THE SECOND PATIENT. REFER TO 2026095-2017-00166 FOR THE FOURTH PATIENT. REFER TO 2026095-2017-00167 FOR THE FIFTH PATIENT. REFER TO 2026095-2017-00168 FOR THE SIXTH PATIENT. REFER TO 2026095-2017-00169 FOR THE SEVENTH PATIENT. REFER TO 2026095-2017-00170 FOR THE EIGHTH PATIENT. REFER TO 2026095-2017-00171 FOR THE NINTH PATIENT. REFER TO 2026095-2017-00172 FOR THE TENTH PATIENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT 10 DEVICES UNDER THE SAME BATCH NUMBER HAD INFUSED FASTER THAN EXPECTED. INSTEAD OF 24 HOURS SCHEDULED INFUSION, THEY COMPLETED IN 12 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6873702 ↗
• MalfunctionSep 18, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TEN DIFFERENT PATIENTS. THIS IS THE SECOND OF TEN REPORTS. REFER TO 2026095-2017-00163 FOR THE FIRST PATIENT. REFER TO 2026095-2017-00165 FOR THE THIRD PATIENT. REFER TO 2026095-2017-00166 FOR THE FOURTH PATIENT. REFER TO 2026095-2017-00167 FOR THE FIFTH PATIENT. REFER TO 2026095-2017-00168 FOR THE SIXTH PATIENT. REFER TO 2026095-2017-00169 FOR THE SEVENTH PATIENT. REFER TO 2026095-2017-00170 FOR THE EIGHTH PATIENT. REFER TO 2026095-2017-00171 FOR THE NINTH PATIENT. REFER TO 2026095-2017-00172 FOR THE TENTH PATIENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT 10 DEVICES UNDER THE SAME BATCH NUMBER HAD INFUSED FASTER THAN EXPECTED. INSTEAD OF 24 HOURS SCHEDULED INFUSION, THEY COMPLETED IN 12 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6873692 ↗

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