AVANOS 13566Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00193494135669), received between Feb 18, 2021 and Jun 5, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025Improper Flow or Infusion; Improper Flow or Infusion

  FILL VOLUME: 201ML ML FLOW RATE: 2 ML/HR PROCEDURE: UNKNOWN CATHPLACE: UNKNOWN INFUSION START TIME: (B)(6) 2025 AT 14:44 INFUSION STOP TIME: (B)(6) 2025 AT 10:55. IT WAS REPORTED, PATIENT RECEIVING 200ML 5FU OVER 96 HOURS HOWEVER, IT FINISHED 1 DAY BEFORE SCHEDULED TO BE COMPLETED. PATIENT HAD NO MEDICAL INTERVENTION OR INJURY DUE TO INCIDENT. SHE ALSO RECEIVED RADIATION. PER ADDITIONAL INFORMATION RECEIVED ON 21MAY2025, PUMP FINISHED 24 HOURS EARLIER THAN EXPECTED WITH NO REMAINING FLUID LEFT. THE TUBING WAS KEPT OUTSIDE OF THE PATIENTS CLOTHING. IT¿S UNKNOWN IF AN AVANOS BRANDED CATHETER WAS USED WITH THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150570 ↗
• MalfunctionJun 24, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL 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 2026095-2024-00032 FOR THE FIRST EVENT. FILL VOLUME: 201 ML, FLOW RATE: UNKNOWN, PROCEDURE: CHEMOTHERAPY, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT'S CHEMOTHERAPY INFUSION WAS SET TO INFUSE (20ML FUOROURACIL + 181ML SODIUM CHLORIDE 0.9%) OVER 96-HOURS AND ENDED IN 71-HOURS. THE DEVICE WAS KEPT BELOW THE INFUSION SITE, AT OR BELOW WAISTLINE (IN PATIENT'S FANNY PACK). THE AMBIENT TEMPERATURE IN THE AREA THE PUMP WAS BEING USED WAS VARIABLE, HOWEVER, THE PATIENT REPORTS HOME AIR CONDITIONING IS KEPT AROUND 72 DEGREES. THE DEVICE WAS HOOKED UP TO PATIENT WITHIN AN HOUR OF PREPARATION. THE PREPARED MEDICATION WAS STORED AT ROOM TEMPERATURE UNTIL ADMINISTERED. THE "PATIENT REPORTED SLIGHT MORE DIZZINESS THAN TYPICAL, BUT THIS IS A COMMON SIDE EFFECT THEY HAVE."

  Patient problems: Dizziness

  MAUDE report 19595664 ↗
• MalfunctionJun 24, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL 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 2026095-2024-00033 FOR THE SECOND EVENT. FILL VOLUME: 201 ML. FLOW RATE: UNKNOWN. PROCEDURE: CHEMOTHERAPY. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT'S CHEMOTHERAPY INFUSION WAS SET TO INFUSE ADRUCILOVER OVER 96-HOURS AND ENDED, "COMPLETELY DEFLATED" IN 67-HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19595650 ↗
• MalfunctionApr 11, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 243 ML FLOW RATE: UNKNOWN PROCEDURE: MASTOPEXY SURGERY WITH IMPLANTS DEVICE PLACED: (B)(6) 2024 CATHPLACE: UNKNOWN IT WAS REPORTED THE PUMP WAS INSTALLED WITH PAIN CONTROL MEDICATION FOR 5-DAYS OF TREATMENT (120-HOURS), WITH A TOTAL VOLUME OF 243 ML. AT APPROXIMATELY 91-HOURS OF TREATMENT, THE DEVICE WAS ALMOST FINISHED (REMAINING VOLUME COMPATIBLE FOR ABOUT 5-HOURS OF TREATMENT). THE TREATMENT WAS SCHEDULED FOR 120-HOURS BUT LASTED APPROXIMATELY 96-HOURS. THE CLINICIANS RECALCULATED THE DRUG DOSAGE AND CHANGED THE INFUSER TO COMPLETE THE DAYS OF TREATMENT. THE PATIENT WAS REPORTED TO BE STABLE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088151 ↗
• MalfunctionApr 11, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 243 ML. FLOW RATE: UNKNOWN . PROCEDURE: TIBIA OSTEOTOMY SURGERY. DATE OF PROCEDURE: (B)(6) 2024. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP WAS INSTALLED WITH MEDICATION FOR PAIN CONTROL FOR 5-DAYS OF TREATMENT, WITH A TOTAL VOLUME OF (B)(4). AFTER 65-HOURS OF TREATMENT, THE DEVICE HAD A VOLUME OF MEDICATION MUCH LOWER THAN WHAT SHOULD BE LEFT FOR THAT TIME. THE FOLLOWING DAY, AT APPROXIMATELY 90-HOURS OF TREATMENT, THE DEVICE WAS FOUND TO BE ALMOST WITHOUT MEDICATION, WITH 30-HOURS LEFT TO COMPLETE THE PATIENT'S 120-HOUR TREATMENT. THE CLINICIANS RECALCULATED THE DRUG DOSAGE AND CHANGED THE INFUSER TO COMPLETE THE DAYS OF TREATMENT. THE PATIENT WAS REPORTED TO BE STABLE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088129 ↗
• MalfunctionApr 11, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 243 ML. FLOW RATE: UNKNOWN . PROCEDURE: KNEE SURGERY . DATE OF PROCEDURE: (B)(6) 2024. CATHPLACE: UNKNOWN. IT WAS REPORTED THE DEVICE WAS INSTALLED ON (B)(6) 2024 AT 5:15 PM WITH MEDICATION FOR PAIN CONTROL FOR 5-DAYS OF TREATMENT, WITH A TOTAL VOLUME OF 243 ML. AT APPROXIMATELY 73-HOURS OF TREATMENT THAT THE VOLUME OF MEDICATION DID NOT CORRESPOND TO WHAT IT SHOULD TO THE TIME OF EVOLUTION (LESS VOLUME OF MEDICATION IS EVIDENCED). THE NEXT DAY, APPROXIMATELY 99-HOURS OF TREATMENT, THE DEVICE WAS ALMOST EMPTY, WITH 21-HOURS OF TREATMENT REMAINING TO COMPLETE THE 120-HOURS OF TREATMENT." THE CLINICIANS RECALCULATED THE DRUG DOSAGE AND CHANGED THE INFUSER TO COMPLETE THE DAYS OF TREATMENT. PATIENT WAS REPORTED TO BE STABLE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088123 ↗
• MalfunctionJul 27, 2023Improper Flow or Infusion; Improper Flow or Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 2026095-2023-00081 FOR THE FIRST REPORT. REFER TO 2026095-2023-00082 FOR THE SECOND REPORT. REFER TO 2026095-2023-00083 FOR THE THIRD REPORT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, THE HOMEPUMP C SERIES INFUSED EARLIER THAN EXPECTED. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17410239 ↗
• MalfunctionJul 27, 2023Improper Flow or Infusion; Improper Flow or Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 2026095-2023-00081 FOR THE FIRST REPORT. REFER TO 2026095-2023-00082 FOR THE SECOND REPORT. REFER TO 2026095-2023-00084 FOR THE FOURTH REPORT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, THE HOMEPUMP C SERIES INFUSED EARLIER THAN EXPECTED. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17410217 ↗
• MalfunctionJul 27, 2023Improper Flow or Infusion; Improper Flow or Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 2026095-2023-00081 FOR THE FIRST REPORT. REFER TO 2026095-2023-00083 FOR THE THIRD REPORT. REFER TO 2026095-2023-00084 FOR THE FOURTH REPORT. FILL VOLUME: 201 ML. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, THE HOMEPUMP C SERIES INFUSED EARLY, WITHIN 24-28 HOURS. THE INTENDED INFUSION TIME WAS 96 HOURS. THE PATIENT DID NOT EXPERIENCE ANY SIDE EFFECTS. THE PUMP WAS FILLED ON (B)(6) 2023. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410215 ↗
• MalfunctionJul 27, 2023Improper Flow or Infusion; Improper Flow or Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 2026095-2023-00082 FOR THE SECOND REPORT. REFER TO 2026095-2023-00083 FOR THE THIRD REPORT. REFER TO 2026095-2023-00084 FOR THE FOURTH REPORT. FILL VOLUME: 201 ML UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, THE HOMEPUMP C SERIES INFUSED EARLY, WITHIN 24-28 HOURS. THE INTENDED INFUSION TIME WAS 96 HOURS. THE PUMP WAS FILLED ON (B)(6) 2023. THE PATIENT DID NOT EXPERIENCE ANY SIDE EFFECTS. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410212 ↗
• InjuryMay 8, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 192 ML, FLOW RATE: 2 ML/HR, PROCEDURE: CHEMOTHERAPY, CATHPLACE: UNKNOWN, INFUSION START TIME: (B)(6) 2022, INFUSION STOP TIME: (B)(6) 2022. IT WAS REPORTED THAT THE C SERIES PUMP INFUSED ONE DAY EARLY; THE INTENDED LENGTH OF INFUSION WAS TO BE FOUR DAYS. THE PATIENT REPORTEDLY EXPERIENCED GASTROINTESTINAL (GI) DISTRESS AS A RESULT OF THE FAST FLOW INCIDENT. NO MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED GI DISTRESS.

  Patient problems: Nausea; Unspecified Gastrointestinal Problem

  MAUDE report 14332544 ↗
• MalfunctionFeb 18, 2021Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 08-MAR-2021 VIA FDA MEDWATCH / FDA USER FACILITY REPORT #MW5099150. THE FOLLOWING INFORMATION WAS PROVIDED: [PATIENT] PT RECEIVED HALYARD HOMEPUMP C SERIES ELASTOMERIC PUMP MODEL # C270020 270ML/HR TO INFUSE FLUOROURACIL OVER 96 HOURS. PUMP ATTACHED AT (B)(6) 2021 AT 1228. CLINIC CONTACTED (B)(6) 2021 [AT] 1131 THAT PATIENT WAS CONCERNED THAT THE PUMP WAS EMPTY AND THAT SHE NOTICED IT EMPTY LAST NIGHT WHEN THE PT ARRIVED AT CLINIC, RN CONFIRMED THE CORRECT PUMP WAS DISPENSED AND CALCULATIONS WERE CORRECT. NO OBVIOUS LEAKS OR DEFECTS WITH PUMP PER PT. PT EXPERIENCED NAUSEA AND MOUTH SORES FROM SHORTER THAN EXPECTED DURATION OF INFUSION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nausea

  MAUDE report 11345942 ↗

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