ANCORIS* ATAS-6-NSBRecalls & reported problems
Avanos Medical, Inc. · Tube Anchor Set · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770003757), received between Jul 17, 2024 and Jul 17, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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
- Detachment of Device or Device Component2
- Unintended Movement2
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2024Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2024-00133 FOR THE FIRST REPORT. IT WAS REPORTED, AN ANCORIS CLIP BECAME DETACHED FROM THE ADHESIVE WHILE ON THE BABY CAUSING THEIR TUBE TO DANGLE AND MIGRATE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19765095 ↗MalfunctionJul 17, 2024Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement
PER ADDITIONAL INFORMATION RECEIVED ON 23JUL2024, ¿THERE WAS NO PATIENT INJURY OR NEEDED MEDICAL INTERVENTION.¿.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19765090 ↗
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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