Halyard 13480Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10680651134803), received between Jan 3, 2019 and Jan 3, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE THIRD OF THREE EVENTS. REFER TO 2026095-2018-00176 FOR THE FIRST EVENT. REFER TO 2026095-2018-00177 FOR THE SECOND EVENT. FILL VOLUME: 400 ML; FLOW RATE: 5 ML/HR; PROCEDURE: SHOULDER SURGERY; CATHPLACE: POSITIONED ON TOP OF INTERSCALENE (BRACHIAL PLEXUS) NERVE/ IT WAS INITIALLY REPORTED THAT A CUSTOMER EXPERIENCED AN BUTTON ISSUE ASSOCIATED WITH THE USE OF AN ELASTOMERIC PUMP. THE PATIENT HAD SHOULDER SURGERY AND IT WAS NOTED THAT THE BOLUS BUTTONS OF THREE ON DEMAND PUMPS DID NOT POP BACK UP AFTER USAGE. THE BOLUS RESERVOIR DID NOT FILL AND NO LONGER WORKED. ADDITIONAL INFORMATION RECEIVED ON 11-DEC-2018 STATED THAT THE PRIMING TAB WAS REMOVED PRIOR TO PATIENT USE AND FILLED BY THE PHARMACY HOSPITAL. IT WAS NOTED THAT THE BOLUS BUTTON WAS DEPRESSED FIRST IN THE HOSPITAL AND THEN LATER AT HOME WITH THE PATIENT. NO SPECIFIC INFORMATION ON HOW MANY TIMES IT WAS DEPRESSED AT HOME. THE PATIENT STRUGGLED A LOT WITH THE USE OF THE BOLUS BUTTON. IT WAS NOTED THAT THE BOLUS BUTTON WAS STUCK AND DID NOT POP BACK UP

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8211860 ↗
• MalfunctionJan 3, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE SECOND OF THREE EVENTS. REFER TO 2026095-2018-00176 FOR THE FIRST EVENT. REFER TO 2026095-2018-00178 FOR THE THIRD EVENT. FILL VOLUME: 400 ML. FLOW RATE: 5 ML/HR. PROCEDURE: SHOULDER SURGERY. CATHPLACE: POSITIONED ON TOP OF INTERSCALENE (BRACHIAL PLEXUS) NERVE. IT WAS INITIALLY REPORTED THAT A CUSTOMER EXPERIENCED AN BUTTON ISSUE ASSOCIATED WITH THE USE OF AN ELASTOMERIC PUMP. THE PATIENT HAD SHOULDER SURGERY AND IT WAS NOTED THAT THE BOLUS BUTTONS OF THREE ON DEMAND PUMPS DID NOT POP BACK UP AFTER USAGE. THE BOLUS RESERVOIR DID NOT FILL AND NO LONGER WORKED. ADDITIONAL INFORMATION RECEIVED ON 11-DEC-2018 STATED THAT THE PRIMING TAB WAS REMOVED PRIOR TO PATIENT USE AND FILLED BY THE PHARMACY HOSPITAL. IT WAS NOTED THAT THE BOLUS BUTTON WAS DEPRESSED FIRST IN THE HOSPITAL AND THEN LATER AT HOME WITH THE PATIENT. NO SPECIFIC INFORMATION ON HOW MANY TIMES IT WAS DEPRESSED AT HOME. THE PATIENT STRUGGLED A LOT WITH THE USE OF THE BOLUS BUTTON. IT WAS NOTED THAT THE BOLUS BUTTON WAS STUCK AND DID NOT POP BACK UP

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8211846 ↗
• MalfunctionJan 3, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE FIRST OF THREE EVENTS. REFER TO 2026095-2018-00177 FOR THE SECOND EVENT. REFER TO 2026095-2018-00178 FOR THE THIRD EVENT. FILL VOLUME: 400 ML. FLOW RATE: 5 ML/HR. PROCEDURE: SHOULDER SURGERY. CATHPLACE: POSITIONED ON TOP OF INTERSCALENE (BRACHIAL PLEXUS) NERVE. IT WAS INITIALLY REPORTED THAT A CUSTOMER EXPERIENCED AN BUTTON ISSUE ASSOCIATED WITH THE USE OF AN ELASTOMERIC PUMP. THE PATIENT HAD SHOULDER SURGERY AND IT WAS NOTED THAT THE BOLUS BUTTONS OF THREE ONDEMAND PUMPS DID NOT POP BACK UP AFTER USAGE. THE BOLUS RESERVOIR DID NOT FILL AND NO LONGER WORKED. ADDITIONAL INFORMATION RECEIVED ON 11-DEC-2018 STATED THAT THE PRIMING TAB WAS REMOVED PRIOR TO PATIENT USE AND FILLED BY THE PHARMACY HOSPITAL. IT WAS NOTED THAT THE BOLUS BUTTON WAS DEPRESSED FIRST IN THE HOSPITAL AND THEN LATER AT HOME WITH THE PATIENT. NO SPECIFIC INFORMATION ON HOW MANY TIMES IT WAS DEPRESSED AT HOME. THE PATIENT STRUGGLED A LOT WITH THE USE OF THE BOLUS BUTTON. IT WAS NOTED THAT THE BOLUS BUTTON WAS STUCK AND DID NOT POP BACK UP

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8211831 ↗

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