Halyard 13736Recalls & reported problems
Avanos Medical, Inc. · HALYARD* ON-Q* Disposable Tunnelers & Sheaths 16 GA x 12 in · Class 2
All models of Halyard (232)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651137361), received between Apr 18, 2018 and Apr 18, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2018Break; Break
IT WAS REPORTED THAT THE DOCTOR PERFORMED AND INITIAL PLACEMENT ON A PATIENT. THE PATIENT WAS IN THE RIGHT LATERAL RECUMBENT POSITION WITH NO ISSUES UPON THE INSERTION. THE CATHETER WAS PLACED BOTTOM TO TOP TO A DEPTH OF 15 CM AND ROPIVACAIN WAS USED TO BOLUS. WHEN THE SHEATH WAS PEELED AWAY THE HEALTHCARE PROFESSIONAL FELT LIKE IT BROKE LEAVING A PIECE BEHIND. THE DOCTOR REMOVED THE CATHETER IN AN ATTEMPT TO RETRIEVE THE BROKEN PIECE, HOWEVER, THAT WAS UNSUCCESSFUL. AN ULTRASOUND WAS USED TO VERIFY IF THERE WAS A MISSING PIECE AND THE ULTRASOUND CONFIRMED THE RETAINED COMPONENT INSIDE THE PATIENT. THE DOCTOR FELT THAT A SECONDARY INCISION WAS NECESSARY TO LOCATE THE REMAINING PIECE. A 4¿ INCISION WAS MADE, BUT THE HEALTHCARE PROFESSIONALS WERE UNABLE TO LOCATE THE PIECE. RATHER THAN CAUSE MORE TRAUMA TO THE AREA, THE TEAM DECIDED TO ABORT AND LET THE SURGEON TRY TO PERFORM THE RIB FRACTURE REPAIR. THE NEXT DAY THE PATIENT UNDERWENT SURGERY TO FIX THE RIB FRACTURE. THE DOCTOR PERFORMED THE SURGERY, BUT COULD NOT LOCATE OR SEE THE MISSING PIECE. THE PATIENT EXPERIENCED A NORMAL RECOVERY DESPITE NOT LOCATING THE MISSING PIECE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 7439668 ↗
Other PUMP, INFUSION, ELASTOMERIC devices
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- Halyard 13568Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC86 reports
- ON-Q* Pain Relief System with SELECT-A-FLOW 13472Avanos Medical, Inc. · Pump, infusion, elastomeric73 reports
- Halyard 13472Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC68 reports
- EASYPUMP 4540008-02B. Braun Medical Inc. · PUMP, INFUSION, ELASTOMERIC54 reports
- DOSI-FUSER L25915-500D1-USALeventon Sau · Pump, Infusion, Elastomeric1 recall0 reports
- DOSI-FUSER L25915-600D1-USALeventon Sau · Pump, Infusion, Elastomeric1 recall0 reports
- Halyard 13561Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC42 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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