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Halyard 45609Recalls & reported problems

Avanos Medical, Inc. · HALYARD* Enteral Device Declogging System · 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 10680651456097), received between Feb 20, 2020 and Feb 20, 2020 — 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
  • Detachment of Device or Device Component1

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.

  • MalfunctionFeb 20, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    FDA MEDWATCH / FDA USER FACILITY REPORT #: (B)(4) RECEIVED ON 31-JAN-2020, AND THE FOLLOWING INFORMATION WAS PROVIDED: "PATIENT HAD A CLOGGED PEG FEEDING TUBE, CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM OBTAINED TO ATTEMPT TO DECLOG THE NG [NASOGASTRIC] TUBE. INSTRUCTIONS FOLLOWED BY RN [REGISTERED NURSE] TO INSTILL DECLOTTING LIQUID WITH APPLICATOR AND PLASTIC TUBE. WHEN PLASTIC TUBE REMOVED IT BROKE LEAVING 6 INCHES OF PLASTIC TUBING. PATIENT WENT TO IR [INTERVENTIONAL RADIOLOGY] TO HAVE PEG TUBE REMOVED AND REPLACED, PLASTIC TUBING COULD NOT BE LOCATED." "DEVICE FAILED (E G BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)." ADDITIONAL INFORMATION RECEIVED 03-FEB-2020 INDICATED THE PATIENT IS STABLE.

    Patient problems: Foreign Body In Patient

    MAUDE report 9734883 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

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Sources and updates

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