Avalign VM82-7222Recalls & reported problems
Avalign Technologies, Inc. · Kray Hook · Class 1
- 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 00190776068103), received between Dec 6, 2024 and Dec 6, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
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.
MalfunctionDec 6, 2024Material Fragmentation; Material Fragmentation
ON 11/06/2024, AVALIGN GSI QUALITY RECEIVED A CUSTOMER COMPLAINT FROM STERIS CORPORATION. STERIS CORP REPORTED THAT THEIR CUSTOMER, THE NEBRASKA MEDICAL CENTER,REPORTED TO THEM THAT THEY HAD TWO (2) UNITS OF CUSTOMER PART# VM82-7222 THAT THE BALL TIPS BROKE OFF DURING A CASE. THEY WERE REMOVED WITH NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20863290 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.