AVANOS 13560Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00193494135607), received between Jun 7, 2022 and Oct 24, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 100ML. FLOW RATE: 0.5 ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: PORT CATHETER. DEVICE START DATE: (B)(6) 2024. DEVICE END DATE: (B)(6) 2024. IT WAS REPORTED, "THE PUMP EMPTIED ON DAY-3 INSTEAD OF SUPPOSED DURATION (5 DAYS)." THE PUMP AND TUBING WERE UNDER THE PATIENT'S CLOTHING, BLANKET AND THE FLOW RESTRICTOR WAS TAPED TO THE PATIENT'S SKIN. TUBING UNDER CLOTHING/BLANKET. THE DEVICE WAS FILLED USING A SYRINGE ON (B)(6) 2024. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523749 ↗
• MalfunctionJun 7, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 2026095-2022-00057 FOR THE FIRST EVENT. REFER TO 2026095-2022-00058 FOR THE SECOND EVENT. REFER TO 2026095-2022-00059 FOR THE THIRD EVENT. REFER TO 2026095-2022-00061 FOR THE FOURTH EVENT. FILL VOLUME: 84 ML, FLOW RATE: 0.5 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP DID NOT LAST THE EXPECTED 7-DAYS. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14628100 ↗
• MalfunctionJun 7, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 2026095-2022-00057 FOR THE FIRST EVENT. REFER TO 2026095-2022-00058 FOR THE SECOND EVENT. REFER TO 2026095-2022-00061 FOR THE FIFTH EVENT. FILL VOLUME: 84 ML. FLOW RATE: 0.5 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP DID NOT LAST THE EXPECTED 7-DAYS. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14628073 ↗
• MalfunctionJun 7, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 2026095-2022-00057 FOR THE FIRST EVENT. REFER TO 2026095-2022-00058 FOR THE SECOND EVENT. REFER TO 2026095-2022-00059 FOR THE THIRD EVENT. FILL VOLUME: 84 ML, FLOW RATE: 0.5 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP DID NOT LAST THE EXPECTED 7-DAYS. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14628072 ↗
• MalfunctionJun 7, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 2026095-2022-00057 FOR THE FIRST EVENT. REFER TO 2026095-2022-00060 FOR THE FOURTH EVENT. REFER TO 2026095-2022-00061 FOR THE FIFTH EVENT. FILL VOLUME: 84 ML, FLOW RATE: 0.5 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP DID NOT LAST THE EXPECTED 7-DAYS. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14628070 ↗
• MalfunctionJun 7, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 2026095-2022-00059 FOR THE THIRD EVENT. REFER TO 2026095-2022-00060 FOR THE FOURTH EVENT. REFER TO 2026095-2022-00061 FOR THE FIFTH EVENT. FILL VOLUME: 84 ML, FLOW RATE: 0.5 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP DID NOT LAST THE EXPECTED 7-DAYS. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14628068 ↗

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