CODMAN® CERTAS™ Plus 828852Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® CERTAS® Plus Electronic Tool Kit · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780532897), received between Oct 4, 2024 and Nov 7, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Excessive Heating” (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
- Excessive Heating1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2025Overheating of Device; Overheating of Device
A PHYSICIAN REPORTED A BURNING SMELL DURING USE OF A CERTAS ELECTRONIC TOOL KIT (ID 828852). IT WAS CONFIRMED THAT THE BATTERY WAS OVERHEATING. THE DEVICE WOULD NOT TURN ON EVEN AFTER REPLACING THE BATTERY. THE NEW BATTERY ALSO OVERHEATED. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY REPORTED, AND THE EVENT DID NOT LED TO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23497139 ↗MalfunctionOct 4, 2024Excessive Heating; Excessive Heating
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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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