Halyard 44939Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651449396), received between Dec 16, 2019 and Dec 16, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K063530); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  PER ADDITIONAL INFORMATION RECEIVED 01 OCT 2020, THE DISTANCE OF THE PUMP TO THE CATHETER SITE WAS 40CM, AND THE PUMP WAS AT ROOM TEMPERATURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9472804 ↗
• MalfunctionDec 16, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2019-00203 FOR THE FIRST REPORT. FILL VOLUME: 270 ML, FLOW RATE: 7ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: FEMORAL, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. PARALLEL TO THE EXISTING PUMP, A NEW PUMP WAS ATTACHED TO THE PATIENT AND RUN WITH THE SAME SETTINGS. AFTER ONE HOUR, IT WAS DETERMINED THAT 15ML HAD BEEN DISPENSED. THE PUMP WAS IMMEDIATELY STOPPED AND A CLINICAL CHECK WAS PERFORMED. PER ADDITIONAL INFORMATION RECEIVED 5 DEC 2019, THERE WERE NO CONSEQUENCES OR SIDE EFFECTS TO THE PATIENT. NO FURTHER MEDICAL INTERVENTION WAS NEEDED. THE PUMP WAS NOT NEAR A HEATING SYSTEM AND NOT AGAINST THE PATIENT'S BODY. THE DRUG USED WAS ROPIVACAINE 0.2%.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9472803 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063530. One submission often covers many models, so check the product and lot details in each record.

• Z-2860-2011 · Apr 15, 2011 · Terminated
  I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for p
• Z-2133-2008 · Feb 14, 2008 · Terminated
  On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narc
• Z-1869-2008 · Feb 12, 2008 · Terminated
  ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anest