Aurora® Surgiscope® ASX9/100Recalls & 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
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850002332285), received between Jan 6, 2025 and Jan 6, 2025 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K232618); they may or may not involve this specific model.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Convulsion/Seizure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
Recalls under the same FDA submission
These recalls involve devices cleared under K232618. One submission often covers many models, so check the product and lot details in each record.
- Z-2331-2024 · Jun 7, 2024 · Open, ClassifiedAURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Other RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY devices
- AURORA® Surgiscope® ASX15/60Integra Lifesciences Corporation · Retractor, Self-Retaining, For Neurosurgery1 recall1 report
- 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
- 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
- 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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