Halyard 44271Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10680651442717), received between Jul 20, 2017 and Jul 20, 2017 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING A SINGLE PATIENT. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 2026095-2017-00136 FOR THE FIRST EVENT. REFER TO 2026095-2017-00137 FOR THE SECOND EVENT. REFER TO 2026095-2017-00138 FOR THE THIRD EVENT. REFER TO 2026095-2017-00139 FOR THE FOURTH EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THAT THE INFUSION WAS TOO QUICK. THE DRUG INFUSED IN FIVE TO TWELVE HOURS INSTEAD OF 24 HOURS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6727945 ↗
• MalfunctionJul 20, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING A SINGLE PATIENT. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 2026095-2017-00136 FOR THE FIRST EVENT. REFER TO 2026095-2017-00137 FOR THE SECOND EVENT. REFER TO 2026095-2017-00139 FOR THE FOURTH EVENT. REFER TO 2026095-2017-00140 FOR THE FIFTH EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THAT THE INFUSION WAS TOO QUICK. THE DRUG INFUSED IN FIVE TO TWELVE HOURS INSTEAD OF 24 HOURS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6727942 ↗
• MalfunctionJul 20, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING A SINGLE PATIENT. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 2026095-2017-00136 FOR THE FIRST EVENT. REFER TO 2026095-2017-00137 FOR THE SECOND EVENT. REFER TO 2026095-2017-00138 FOR THE THIRD EVENT. REFER TO 2026095-2017-00140 FOR THE FIFTH EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THAT THE INFUSION WAS TOO QUICK. THE DRUG INFUSED IN FIVE TO TWELVE HOURS INSTEAD OF 24 HOURS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6727941 ↗
• MalfunctionJul 20, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING A SINGLE PATIENT. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 2026095-2017-00137 FOR THE SECOND EVENT. REFER TO 2026095-2017-00138 FOR THE THIRD EVENT. REFER TO 2026095-2017-00139 FOR THE FOURTH EVENT. REFER TO 2026095-2017-00140 FOR THE FIFTH EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THAT THE INFUSION WAS TOO QUICK. THE DRUG INFUSED IN FIVE TO TWELVE HOURS INSTEAD OF 24 HOURS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6727937 ↗
• MalfunctionJul 20, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING A SINGLE PATIENT. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 2026095-2017-00136 FOR THE FIRST EVENT. REFER TO 2026095-2017-00138 FOR THE THIRD EVENT. REFER TO 2026095-2017-00139 FOR THE FOURTH EVENT. REFER TO 2026095-2017-00140 FOR THE FIFTH EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THAT THE INFUSION WAS TOO QUICK. THE DRUG INFUSED IN FIVE TO TWELVE HOURS INSTEAD OF 24 HOURS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6727933 ↗

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