Halyard 13646Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10680651136463), received between Aug 16, 2018 and May 6, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

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

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: BREAST SURGERY, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2019-00078 FOR THE FIRST REPORT. REFER TO 2026095-2019-00080 FOR THE THIRD REPORT. IT WAS REPORTED THAT A FAST FLOW EVENT OCCURRED. THREE UNITS ARE INVOLVED. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8584454 ↗
• MalfunctionMay 6, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: BREAST SURGERY, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2019-00078 FOR THE FIRST REPORT. REFER TO 2026095-2019-00079 FOR THE SECOND REPORT. IT WAS REPORTED THAT A FAST FLOW EVENT OCCURRED. THREE UNITS ARE INVOLVED. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8584453 ↗
• MalfunctionMay 6, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 330 ML, FLOW RATE: 5ML/HR, PROCEDURE: BREAST SURGERY, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2019-00079 FOR THE SECOND REPORT. REFER TO 2026095-2019-00080 FOR THE THIRD REPORT. IT WAS REPORTED THAT A FAST FLOW EVENT OCCURRED. "AFTER 46 HOURS ONLY 55ML WAS LEFT, INSTEAD OF APPROX 100[ML]." THREE UNITS ARE INVOLVED. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8584415 ↗
• MalfunctionAug 16, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 110 ML, FLOW RATE: 8 ML/HR AND 14 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, DATE/TIME INFUSION START: 12:27 PM, DATE/TIME INFUSION STOP: UNSURE IF IT OCCURRED AM OR PM. IT WAS REPORTED THE ON-Q PUMP RAN FASTER THAN INTENDED. THERE WAS NO REPORTED PATIENT INJURY. WHEN THE INCIDENT OCCURRED THE PATIENT WAS ON THE SURGICAL INPATIENT UNIT. WHEN THE ISSUE WAS IDENTIFIED THE ON-Q DEVICE WAS ON TOP OF THE BED SHEETS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7788735 ↗

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