Halyard 13479Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10680651134797), received between Jun 28, 2017 and Nov 6, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 420 ML. FLOW RATE: 10 ML/HR. PROCEDURE: KNEE PROSTHESIS. CATHPLACE: KNEE INTRA-ARTICULAR CATHETER. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT AFTER 30 HOURS, THE PUMP WAS EMPTY. THERE WAS NO ADVERSE EVENT RELATED TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8044223 ↗
• MalfunctionNov 6, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 2026095-2018-00116 FOR THE FIRST REPORT. REFER TO 2026095-2018-00117 FOR THE SECOND REPORT. REFER TO 2026095-2018-00118 FOR THE THIRD REPORT. IT WAS REPORTED THERE WAS AN OVER-INFUSION EVENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8044208 ↗
• MalfunctionNov 6, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 2026095-2018-00117 FOR THE SECOND REPORT. REFER TO 2026095-2018-00118 FOR THE THIRD REPORT. REFER TO 2026095-2018-00119 FOR THE FOURTH REPORT. IT WAS REPORTED THERE WAS AN OVER-INFUSION EVENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8044206 ↗
• MalfunctionNov 6, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 2026095-2018-00116 FOR THE FIRST REPORT. REFER TO 2026095-2018-00118 FOR THE THIRD REPORT. REFER TO 2026095-2018-00119 FOR THE FOURTH REPORT. IT WAS REPORTED THERE WAS AN OVER-INFUSION EVENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8044198 ↗
• MalfunctionNov 6, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 2026095-2018-00116 FOR THE FIRST REPORT. REFER TO 2026095-2018-00117 FOR THE SECOND REPORT. REFER TO 2026095-2018-00119 FOR THE FOURTH REPORT. IT WAS REPORTED THERE WAS AN OVER-INFUSION EVENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8044141 ↗
• MalfunctionJun 28, 2017Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 400 ML, FLOW RATE: 10/ML/HR, PROCEDURE: MIDLINE LAPAROTOMY, CATHPLACE: RECTUS SHEATH BLOCK, DATE/TIME INFUSION START: (B)(6) 2017 PM, DATE/TIME INFUSION STOP: (B)(6) 2017 PM. A REPORT WAS RECEIVED STATING THAT FAST FLOW EVENT HAD OCCURRED. THE DEVICE WAS NOTED TO BE EMPTY WITHIN 24 HOURS OF INITIAL START. ADDITIONAL INFORMATION RECEIVED 14-JUN-2017 STATED THE NURSE DISCOVERED THE EMPTY DEVICE. THE PATIENT WAS ON THE SURGICAL HIGH DEPENDENCY UNIT. THE PATIENT WAS NOT RECEIVING WARMING OR COOLING THERAPY. THE PUMP AND TUBING WAS NOT UNDER A WARMING OR COOLING DEVICE. THE PUMP WAS PLACED UNDER THE BLANKETS BELOW THE INFUSION SITE DURING INFUSION. THERE WAS NO REPORTED INJURY. NO FURTHER INFORMATION TO BE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6673456 ↗

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