Halyard 13569Recalls & reported problems
Avanos Medical, Inc. · HALYARD* HOMEPUMP C-SERIES* Ambulatory Infusion Systems · 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 10680651135695), received between Mar 4, 2020 and Mar 4, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K052117); 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
Device problems
- Excess Flow or Over-Infusion1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
FILL VOLUME: 250 ML. FLOW RATE: UNKNOWN. PROCEDURE: ANTIBIOTIC THERAPY - TEMOCILLIN 5G. CATHPLACE: UNKNOWN. INFUSION START TIME: 6PM UNKNOWN DATE. INFUSION STOP TIME: 9AM NEXT DAY, UNKNOWN DATE. IT WAS REPORTED THAT THE INFUSION OF TEMOCILLIN 5G WAS SUPPOSED TO LAST OVER 24 HOURS. HOWEVER, AT 9AM THE NEXT DAY, THE PATIENT FOUND THAT THERE WAS NO ANTIBIOTIC LEFT IN THE PUMP. THE INFUSION LASTED ONLY 13 HOURS. THERE WAS NO INJURY TO THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED 18 FEB 2020, THE NURSE REPORTED THAT THEY ASSUME THE PUMP WAS UNDER THE BED COVERS, AS IT WAS IN THE BAG ATTACHED TO THE PATIENT'S WAIST.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9785944 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K052117. One submission often covers many models, so check the product and lot details in each record.
- Z-2111-2009 · Feb 11, 2008 · TerminatedI-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico. The Easypump LT is indicated for continuous and/or intermittent infusion of medicatio
- Z-0584-06 · Jan 17, 2006 · TerminatedEasypump ST 100-1 infusion pump
- Z-0585-06 · Jan 17, 2006 · TerminatedEasypump L T 60-24 infusion pump
Other PUMP, INFUSION, ELASTOMERIC devices
- EASYPUMP 4540018-02B. Braun Medical Inc. · PUMP, INFUSION, ELASTOMERIC313 reports
- 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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