Halyard 13473Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10680651134735), received between Jul 13, 2017 and Jul 10, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (4 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 16, 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.

• MalfunctionJul 10, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  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 TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2019-00128 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE PUMP INFUSED TOO QUICKLY. THE PUMP WAS FILLED WITH 100 ML 0.5% BUPIVACAINE/300 ML SODIUM CHLORIDE. NO ADVERSE EFFECTS WERE REPORTED. THE PATIENT WAS HOOKED UP TO THE PUMP ON (B)(6) 2019, AND CLAIMED THE PUMP EMPTIED IN THE FIRST 24 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8779004 ↗
• MalfunctionJul 10, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  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 TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2019-00129 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE PUMP INFUSED TOO QUICKLY. THE PUMP WAS FILLED WITH 100 ML 0.5% BUPIVACAINE/300 ML SODIUM CHLORIDE. NO ADVERSE EFFECTS WERE REPORTED. THE PATIENT WAS HOOKED UP TO THE PUMP ON (B)(6) 2019, AND CLAIMED THE PUMP EMPTIED IN THE FIRST 24 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8779002 ↗
• MalfunctionMay 3, 2019Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE "BOLUS FEATURE DID NOT FUNCTION PROPERLY. PUMP WAS HOOKED UP TO PATIENT AFTER SURGERY. ON POD [POST-OPERATIVE DAY] #1 ANESTHESIA ROUNDED ON PATIENT. PATIENT CLAIMED THEY WERE VERY NUMB AND DIDN¿T LIKE THE FEELING. ANESTHESIA THEN NOTICED THAT THE BOLUS FEATURE WAS NOT FILLING CORRECTLY. THE PATIENT HAD NEVER PRESSED THE BOLUS BUT IT WAS NOT FULL. THE ORANGE INDICATION WAS NOT VISIBLE. THE PUMP WAS REPLACED AND SENT BACK TO PHARMACY." NO PATIENT INJURY WAS REPORTED AND NO SYMPTOMS OF LIDOCAINE TOXICITY EXHIBITED.

  Patient problems: Numbness

  MAUDE report 8579437 ↗
• MalfunctionSep 26, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 400 ML, FLOW RATE: 6 ML/HR, PROCEDURE: SUPRACLAVICULAR PLACEMENT, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT A PATIENT HAD SURGERY ON (B)(6) 2018 AT 11:20 AM AND THE FACILITY CALL THE NEXT DAY AT 10:00 AM FOR A FOLLOW-UP. WHEN THE NURSE CALLED, THE PATIENT STATED THAT THE PUMP WAS EMPTY WHEN SHE WOKE UP. SHE REMOVED THE PUMP AND THREW IT AWAY. THE PATIENT STATED THAT SHE PUSHED THE BOLUS BUTTON ON (B)(6) 2018 AND THE BUTTON DID NOT POP BACK UP WITHIN 60 MINUTES AND THE ORANGE INDICATOR REMAINED AT THE BOTTOM. THE PATIENT WENT TO BED, AND THE NEXT MORNING NOTED THAT THE BED WAS WET AND THE PUMP WAS EMPTY. THE PATIENT DENIED ANY SYMPTOMS OF TOXICITY DURING THE FOLLOW-UP CALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7910510 ↗
• MalfunctionSep 20, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 400 ML. FLOW RATE: 7 ML/HR. PROCEDURE: UNKNOWN . CATHPLACE: UNKNOWN. IT WAS REPORTED THAT A PATIENT CALLED HIS ANESTHESIOLOGIST REPORTING THAT AFTER PUSHING THE BOLUS BUTTON ON THE PAIN BALL, THE CONTENTS EMPTIED INTO HIS SHOULDER. THE PATIENT WENT TO THE EMERGENCY ROOM TO BE EVALUATED. THE PUMP WAS CONNECTED ON (B)(6) 2018 AND THE PATIENT SENT HOME. THE DOCTOR STATED THAT THE PUMP WAS SET TO 7 CC/HR. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7892998 ↗
• MalfunctionJul 13, 2017Mechanical Problem; Mechanical Problem

  CATHPLACE: NECK.

  Patient problems: Pain

  MAUDE report 6712275 ↗

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