CARDINAL HEALTH 65410-010Recalls & reported problems
Cardinal Health 200, LLC · Surgical Cautery - Fine Tip/Low Temp · Class 2
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 00885380001430), received between Aug 16, 2022 and Aug 16, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Energy Output Problem” (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.
Most reported problems
Device problems
- Energy Output 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.
MalfunctionAug 16, 2022Energy Output Problem
THE CUSTOMER ALLEGED THAT THE LOW TEMP CAUTERY TAKES ONE MINUTE TO GET RED HOT. THIS DELAY IN GETTING HOT OCCURRED DURING A CRITICAL POINT IN THE SURGERY WHEN TIMING IS CRUCIAL DUE TO THE MANIPULATION OF TISSUE ALONG WITH THE IMPLANT. THE PATIENT WAS NOT HARMED,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15234183 ↗
Other Unit, cautery, thermal, battery-powered devices
- BVI OME6001UBeaver-Visitec International, Inc. · Unit, cautery, thermal, battery-powered1 recall0 reports
- Accu-Temp® 8445000Beaver-Visitec International, Inc. · Unit, cautery, thermal, battery-powered1 recall0 reports
- Bovie AA01Aspen Surgical Products, Inc. · Unit, Cautery, Thermal, Battery-Powered23 reports
- Bovie AA05Aspen Surgical Products, Inc. · Unit, Cautery, Thermal, Battery-Powered10 reports
- Bovie AA21Aspen Surgical Products, Inc. · Unit, Cautery, Thermal, Battery-Powered4 reports
- Argent 231Mckesson Medical-Surgical Inc. · Unit, Cautery, Thermal, Battery-Powered3 reports
- Accu-Temp® 8442000Beaver-Visitec International, Inc. · Unit, cautery, thermal, battery-powered3 reports
- Argent 244Mckesson Medical-Surgical Inc. · Unit, Cautery, Thermal, Battery-Powered2 reports
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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