Halyard 13483Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10680651134834), received between Mar 9, 2017 and Nov 16, 2018 — classified as 9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2018-00146 FOR THE FIRST EVENT. IT WAS REPORTED BY THE PHYSICIAN THAT THE PATIENT'S BOLUS BUTTON WAS STUCK IN THE DOWN POSITION, RESULTING IN THE PATIENT RECEIVING A CONTINUOUS BOLUS DOSE. THE PHYSICIAN REPLACED THE DEVICE WITH A DIFFERENT DEVICE. PER ADDITIONAL INFORMATION RECEIVED ON 26-OCT-2018 AS THE PREVIOUS ON-Q DEVICE WAS FINISHING, WITHOUT ANY REPORTED ISSUE, THE NURSE CHANGED IT FOR A NEW ONE. AFTER THAT, THE PATIENT ALERTED THE NURSE TO THE ISSUE WITH THE BOLUS BUTTON REMAINING IN THE DOWN POSITION. THE DEVICE WAS CHANGED AGAIN AND THE PATIENT AGAIN WAS RECEIVING CONTINUOUS BOLUS OF ROPIVACAINE DUE TO A PROBLEM WITH THE BOLUS BUTTON REMAINING IN THE DOWN POSITION. THIS DEVICE WAS SWAPPED OUT FOR AN ELECTRONIC PUMP. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8081304 ↗
• MalfunctionNov 16, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2018-00147 FOR THE SECOND EVENT. IT WAS REPORTED BY THE PHYSICIAN THAT THE PATIENT'S BOLUS BUTTON WAS STUCK IN THE DOWN POSITION, RESULTING IN THE PATIENT RECEIVING A CONTINUOUS BOLUS DOSE. THE PHYSICIAN REPLACED THE DEVICE WITH A DIFFERENT DEVICE. PER ADDITIONAL INFORMATION RECEIVED ON 26-OCT-2018 AS THE PREVIOUS ON-Q DEVICE WAS FINISHING, WITHOUT ANY REPORTED ISSUE, THE NURSE CHANGED IT FOR A NEW ONE. AFTER THAT, THE PATIENT ALERTED THE NURSE TO THE ISSUE WITH THE BOLUS BUTTON REMAINING IN THE DOWN POSITION. THE DEVICE WAS CHANGED AGAIN AND THE PATIENT AGAIN WAS RECEIVING CONTINUOUS BOLUS OF ROPIVACAINE DUE TO A PROBLEM WITH THE BOLUS BUTTON REMAINING IN THE DOWN POSITION. THIS DEVICE WAS SWAPPED OUT FOR AN ELECTRONIC PUMP. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8081276 ↗
• MalfunctionOct 26, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 200 ML, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 2026095-2018-00112 FOR THE FIRST REPORT. REFER TO 2026095-2018-00113 FOR THE SECOND REPORT. REFER TO 2026095-2018-00115 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THERE WAS A FAST FLOW EVENT. IT WAS ALLEGED THAT THE PUMP WAS FILLED WITH 200ML AND FINISHED 3 HOUR AND 30 MINUTES FASTER THAN EXPECTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8008995 ↗
• MalfunctionOct 26, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 200 ML, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 2026095-2018-00112 FOR THE FIRST REPORT, REFER TO 2026095-2018-00114 FOR THE THIRD REPORT, REFER TO 2026095-2018-00115 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THERE WAS A FAST FLOW EVENT. IT WAS ALLEGED THAT THE PUMP WAS FILLED WITH 200ML AND FINISHED 1 HOUR AND 30 MINUTES FASTER THAN EXPECTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8008738 ↗
• MalfunctionOct 26, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 400 ML. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 2026095-2018-00113 FOR THE SECOND REPORT. REFER TO 2026095-2018-00114 FOR THE THIRD REPORT. REFER TO 2026095-2018-00115 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THERE WAS A FAST FLOW EVENT. IN THIS CASE, THE PUMP WAS FILLED WITH 400ML OF ROPIVACAINE. THE INFUSION COMPLETED AFTER 16 HOURS INSTEAD OF 40 HOURS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8008734 ↗
• MalfunctionOct 25, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 200 ML, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. IT WAS REPORTED THAT THERE WAS A FAST FLOW EVENT. IT WAS ALLEGED THAT THE PUMP WAS FILLED WITH 200ML AND FINISHED IN 12 HOURS INSTEAD OF 20 HOURS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8006423 ↗
• MalfunctionJul 16, 2018Excess Flow or Over-Infusion; Physical Resistance/Sticking; Excess Flow or Over-Infusion; Physical Resistance/Sticking

  FILL VOLUME: UNKNOWN; FLOW RATE: 10ML/HOUR; PROCEDURE: UNKNOWN; CATHPLACE: UNKNOWN; INFUSION START TIME: UNKNOWN; INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE BOLUS BUTTON WAS NOT WORKING, AND WAS DELIVERING 5ML OF UNKNOWN LOCAL ANESTHETIC EVERY 8 MINUTES, INSTEAD OF EVERY 30 MINUTES. THE PATIENT REPORTED THE ISSUE TO THE NURSE. PER ADDITIONAL INFORMATION RECEIVED 22 JUN 2018, THE PRIMING TAB WAS REMOVED, THE BOLUS INDICATOR WAS IN THE TOP POSITION, AND THE BOLUS BUTTON BECAME STUCK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7690117 ↗
• MalfunctionJul 2, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: UNKNOWN. FLOW RATE: 4ML / H. PROCEDURE: UNKNOWN. CATHPLACE: LEG. INFUSION START TIME: (B)(6) 2018. INFUSION STOP TIME: (B)(6) 2018. IT WAS REPORTED THAT THE PUMP FINISHED EARLIER THAN EXPECTED, 17 HOURS AFTER PLACEMENT, ON (B)(6) 2018. THE PATIENT REPORTED THAT HE DID NOT USE THE BOLUS AND HAS NOT TOUCHED THE DEVICE. THE SHEETS UNDER THE PATIENT ARE NOT WET, AND THE CATHETER BANDAGE IS CLEAN AND DRY. THE POUCH HOLDS THE PUMP ARE NOT WET. THE PATIENT REPORTS THAT "SENSATION OF ANESTHESIA A LITTLE MORE IMPORTANT OF HIS LEG, MANAGES TO MOVE BUT IT IS HEAVIER". NO FURTHER ROPIVACAINE WAS PROVIDED TO THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7655658 ↗
• MalfunctionMar 9, 2017Break; Infusion or Flow Problem; Break; Infusion or Flow Problem

  FILL VOLUME: 440 ML, FLOW RATE: 2-14 ML/HOUR WITH BOLUS 5 ML (FILLING TIME OF 30 MINUTES). A REPORT WAS RECEIVED FROM FRANCE STATING, THE DIFFUSER WAS EMPTIED MUCH FASTER THAN EXPECTED. INSTEAD OF 48-HOURS, IT LASTED 24-HOURS. THE PUMP WAS USED ON A PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6393518 ↗

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