Halyard RYSP93-03_0006Recalls & reported problems
Avid Medical, Inc. · Class 1
Data updated Oct 18, 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 10809160419960), received between Dec 26, 2024 and Dec 26, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Incompatible” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Component Incompatible1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 26, 2024Component Incompatible; Component Incompatible
A MEDWATCH WAS RECEIVED THAT STATED THE SUCTION TUBING COLLAPSED DURING USE. THE PHYSICIAN WAS USING THE CUSTOM SPINE PACK TO PERFORM A POSTERIOR THORACIC FUSION. DURING THE PROCEDURE, THE SUCTION COLLAPSED MAKING IT UNUSABLE. WHILE COLLAPSED, PATIENT CONTINUED TO HAVE PERSISTENT BLEEDING. THE PHYSICIAN INSTRUCTED THE NURSE TO OPEN NEW SUCTION TUBING.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21023758 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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