Halyard 13554Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10680651135541), received between May 2, 2017 and Apr 27, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2020Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION RECEIVED 28-APR-2020 INDICATED "PREPARATION: SOLUMEDROL IN 400ML OF GLUCOSE. TWO (2) PUMPS [WERE] USED ON THE SAME PATIENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10003366 ↗
• MalfunctionApr 27, 2020Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION RECEIVED 28-APR-2020 INDICATED "PREPARATION: SOLUMEDROL IN 400ML OF GLUCOSE. TWO (2) PUMPS [WERE] USED ON THE SAME PATIENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10003364 ↗
• MalfunctionMay 2, 2017Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 400 ML. A REPORT WAS RECEIVED FROM (B)(6) STATING THE HOME PUMP INFUSED IN 2-HOURS AND 30-MINUTES INSTEAD OF 4-HOURS. IT WAS REPORTED THAT THE OUTCOME OF THE FAST FLOW WAS HYPOTENSION.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 6539504 ↗

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