CODMAN CERTAS 82-8851Recalls & reported problems
Medos International Sàrl · CODMAN CERTAS Tool Kit · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704074793), received between Nov 5, 2020 and Aug 10, 2022 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “No Device Output” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- No Device Output2
- Defective Component1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Injury1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2022Defective Component; Defective Component
A FACILITY REPORTED THAT THE PRESSER CHECKING TOOL OF A CERTAS TOOL KIT (ID: 828851) DOES NOT WORK. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15199750 ↗MalfunctionApr 6, 2022No Device Output; No Device Output
A FACILITY REPORTED THE CERTAS TOOL KIT WAS NOT ABLE TO ADJUST THE VALVE SETTING. NO PATIENT INJURY OR CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14021547 ↗MalfunctionMar 29, 2022No Device Output; No Device Output
A FACILITY REPORTED IT WAS NOT POSSIBLE TO ADJUST THE SETTINGS OF A VALVE WITH THE CERTAS TOOL KIT. A REPLACEMENT PRODUCT WAS USED TO ADJUST THE VALVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13943452 ↗InjuryNov 5, 2020Output Problem; Output Problem
A PHYSICIAN REPORTED IT WAS NOT POSSIBLE TO ADJUST THE VALVE. AFTER CHECKING THE INDICATOR TOOL, THE ADJUSTMENT TOOL DOES NOT ADJUST TO THE DESIRED VALVE VALUE, THEREFORE, THE VALVE WAS REVISED/REPLACED. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS.
Patient problems: Injury
MAUDE report 10792451 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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