Halyard 79582Recalls & reported problems
Avanos Medical, Inc. · HYHL100 ANGIOGRAPHY DRAPE-NON-STERL 40 · 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 30680651795824), received between Jan 9, 2025 and Jan 9, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Disintegration” (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.
Reports received per month
Most reported problems
Device problems
- Material Disintegration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2025Material Disintegration; Material Disintegration
A REPORT WAS RECEIVED FROM THE CUSTOMER THAT ALLEGES THE DRAPE WINDOW WAS SEPARATING WHERE THE WINDOW JOINS MATERIAL. THIS INCIDENT COMPROMISED STERILITY DURING THE PROCEDURE. THE CUSTOMER REPORTED THERE WERE THREE LOTS OF DRAPE UTILIZED INCLUDING: GL22282FXX, GL21331FXX & GL23098FXX; HOWEVER, THE CUSTOMER COULD NOT VERIFY WHICH LOT WAS THE ONE THAT EXHIBITED THIS ISSUE DURING PROCEDURE. THE CUSTOMER INDICATED THERE WAS NO PATIENT INJURY OR MEDICAL TREATMENT REQUIRED, ONLY AN IMPACT TO THE STERILE FIELD DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21120752 ↗
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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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