AURORA® Surgiscope® ASX15/60Recalls & reported problems
Integra Lifesciences Corporation · AURORA® Surgiscope® System · Class 2
All models of AURORA Surgiscope (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850002332254), received between Sep 13, 2024 and Sep 13, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Optical Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Feb 6, 2025Class IIOpen, Classified
Possibility for the obturator to break (separate).
Z-1295-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Optical Problem1
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.
MalfunctionSep 13, 2024Optical Problem; Optical Problem
Other Retractor, Self-Retaining, For Neurosurgery devices
- SPOTLIGHT 282915560Depuy Spine, LLC · RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY2 reports
- SPOTLIGHT 282918570Depuy Spine, LLC · RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY1 report
- Symmetry KARLIN™ 46-3191Aspen Surgical Products, Inc. · Retractor, Self-Retaining, For Neurosurgery1 report
- Aurora® Surgiscope® ASX9/100Integra Lifesciences Corporation · RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY1 report
- Symmetry KARLIN™ 46-3204Aspen Surgical Products, Inc. · Retractor, Self-Retaining, For Neurosurgery1 report
- V. Mueller T-1295Steris Corporation · RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY1 report
- Budde® A1040Integra Lifesciences Corporation · RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY1 report
- SPOTLIGHT 282924550Depuy Spine, LLC · RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY1 report
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 · each recall links to the FDA recall notice
- 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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