Halyard 13563Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10680651135633), received between Nov 21, 2018 and Jan 3, 2020 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (6 reports).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 3, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2020-00001 FOR THE FIRST EVENT. REFER TO 2026095-2020-00003 FOR THE THIRD EVENT. FILL VOLUME: 100ML. FLOW RATE: 5 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2019 AT 15:40. INFUSION END TIME: (B)(6) 2019 02:00. IT WAS REPORTED IN THE SECOND CYCLE OF CHEMOTHERAPY OF THE PATIENT DAY-1, THE INFUSION PUMP COMPLETED THE INFUSION IN 11-HOURS INSTEAD OF 20-HOURS. THERE WAS NO REPORTED PATIENT INJURY NOR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9546216 ↗
• MalfunctionJan 3, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2020-00001 FOR THE FIRST EVENT. REFER TO 2026095-2020-00002 FOR THE SECOND EVENT. FILL VOLUME: 100ML. FLOW RATE: 5 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2019 AT 11:12 INFUSION END TIME: (B)(6) 2019 03:00 IT WAS REPORTED IN THE THIRD CYCLE OF CHEMOTHERAPY OF THE PATIENT DAY-2, THE INFUSION PUMP COMPLETED THE INFUSION IN 16-HOURS INSTEAD OF 20-HOURS. THERE WAS NO REPORTED PATIENT INJURY NOR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9546157 ↗
• MalfunctionJan 3, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2020-00002 FOR THE SECOND EVENT. REFER TO 2026095-2020-00003 FOR THE THIRD EVENT. FILL VOLUME: 100ML. FLOW RATE: 5 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2019 AT 15:16. INFUSION END TIME: (B)(6) 2019 06:00. IT WAS REPORTED IN THE THIRD CYCLE OF CHEMOTHERAPY OF THE PATIENT DAY-1, THE INFUSION PUMP COMPLETED THE INFUSION IN 15-HOURS INSTEAD OF 20-HOURS. THERE WAS NO REPORTED PATIENT INJURY NOR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9546136 ↗
• InjurySep 27, 2019Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 125 ML. FLOW RATE: 5 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. DAY / TIME FILLED PUMP: (B)(6) 2019. DAY / TIME START INFUSION: (B)(6) 2019. DAY / TIME END INFUSION: (B)(6) 2019. MEDICATION: 300PU INFUSION OF ROPIVACAINE AND 200 MCG OF FENTANYL/ DILUTED IN 80 ML OF PHYSIOLOGICAL SOLUTION, NORMAL SALINE. IT WAS REPORTED AFTER THE SURGERY, THE POSTOPERATIVE ANALGESIA PUMP INFUSED CONTINUOUSLY. THE DEVICE INFUSED IN 6-HOURS INSTEAD OF 24-HOURS. THE PATIENT EXPERIENCED DIZZINESS, NAUSEA, HYPOTENSION WITH A BLOOD PRESSURE 80/50 MMHG, TACHYCARDIA, SENSORY AND MOTOR BLOCK ON LEGS. MEDICAL INTERVENTION INVOLVED REMOVING THE EQUIPMENT AND ADMINISTERING 1000CC LOAD OF HARTMAN SOLUTION PLUS 10 MG OF EPHEDRINE INTRAVENOUS (IV). THE PUMP WAS ABOVE THE PUMP. THE PATIENT WAS EVENTUALLY DISCHARGED.

  Patient problems: Dizziness; Hyporesponsive to stimuli; Low Blood Pressure/ Hypotension; Nausea; Tachycardia

  MAUDE report 9132164 ↗
• MalfunctionNov 21, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2018-00151 FOR THE FIRST EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED A FAST FLOW EVENT OCCURRED AND THE DEVICE WORKED IN LESS TIME THAN INDICATED. THERE WAS NO REPORTED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8097589 ↗
• MalfunctionNov 21, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2018-00152 FOR THE SECOND EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED A FAST FLOW EVENT OCCURRED AND THE DEVICE WORKED IN LESS TIME THAN INDICATED. THERE WAS NO REPORTED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8097580 ↗

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 · Terminated
  I-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-0585-06 · Jan 17, 2006 · Terminated
  Easypump L T 60-24 infusion pump
• Z-0584-06 · Jan 17, 2006 · Terminated
  Easypump ST 100-1 infusion pump