Halyard 34894Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651348941), received between Mar 6, 2019 and Mar 6, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 89 ML, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PUMP WAS FILLED WITH 89 ML OF 5FU FOR A DURATION OF 44.5 HOURS. THE PUMP COMPLETED 7 HOURS PRIOR TO THE EXPECTED COMPLETION TIME. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8394265 ↗

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