ARveo 8 000000000010449063Recalls & reported problems
Leica Microsystems (Schweiz) AG · ARveo 8 stand system for M530 microscope - for Leica surgical operating microscope system: ARveo 8 · 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 07630003598872), received between Mar 21, 2024 and Mar 21, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Burn(s)1
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM CHINA RELATED TO AN ARVEO 8 STATING THAT A PATIENT WAS DISCOVERED TO HAVE A 2ND DEGREE BURN AFTER SURGERY WAS COMPLETED.
Patient problems: Burn(s); Partial thickness (Second Degree) Burn
MAUDE report 18949123 ↗
Other MICROSCOPE, SURGICAL devices
- M530 Optics Carrier 000000000010448704Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL4 reports
- PROvido 000000000010448950Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL3 reports
- M530 OHX 000000000010448737Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL3 reports
- PROvido 000000000010448976Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL2 reports
- M525 F20 000000000010448284Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL2 reports
- IMAGE1 PILOT TC014Karl Storz GmbH & Co. KG · MICROSCOPE, SURGICAL2 reports
- M530 Optics Carrier 000000000010448700Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL1 report
- 1788 1788210080Stryker Corporation · Microscope, surgical1 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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