VENOM MULTIGEN 2Recalls & reported problems across all models
Stryker Corporation · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 2 models of VENOM MULTIGEN 2 by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Aug 16, 2022 and Apr 29, 2026 — classified as 1 injury, 28 malfunctions.
The most frequently reported specific device problem is “Fracture” (29 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported VENOM MULTIGEN 2 problems
Device problems
- Fracture29
- Degraded4
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Foreign Body In Patient1
VENOM MULTIGEN 2 models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VENOM MULTIGEN 2 8400-825-010GENERATOR, LESION, RADIOFREQUENCY16 reports
- VENOM MULTIGEN 2 8400-825-015GENERATOR, LESION, RADIOFREQUENCY13 reports
Recent VENOM MULTIGEN 2 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Fracture
IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION THE END CAP WAS BROKEN OFF AND MISSING EXPOSING THE THERMOCOUPLE. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25028859 ↗InjuryNov 10, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE ELECTRODE BROKE OFF IN THE PATIENT'S SOFT TISSUE AND AN ADDITIONAL INCISION WAS MADE TO REMOVE THE PIECE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513409 ↗MalfunctionSep 11, 2025Fracture; Fracture
IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION THE SHEATH WAS BROKEN OFF AND MISSING EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23028688 ↗MalfunctionSep 9, 2025Fracture; Fracture
IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION THE SHEATH WAS BROKEN OFF AND MISSING EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23009105 ↗MalfunctionAug 4, 2025Fracture; Fracture
IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION THE SHEATH WAS BROKEN OFF AND MISSING EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22706363 ↗MalfunctionJul 31, 2025Fracture; Fracture
IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION THE SHEATH WAS BROKEN OFF AND MISSING EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22675035 ↗MalfunctionJul 30, 2025Fracture; Fracture
IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION THE SHEATH WAS BROKEN OFF AND MISSING EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22668788 ↗MalfunctionJul 28, 2025Fracture; Fracture
IT WAS REPORTED UPON FUNCTION EVALUATION THAT THE SHEATH WAS BROKEN OFF AND MISSING, EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22631735 ↗MalfunctionJul 28, 2025Fracture; Fracture
IT WAS REPORTED UPON FUNCTION EVALUATION THAT THE SHEATH WAS BROKEN OFF AND MISSING, EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22631734 ↗MalfunctionMay 22, 2025Fracture; Fracture
IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION THE SHEATH WAS BROKEN OFF AND MISSING EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069580 ↗MalfunctionMay 22, 2025Fracture; Fracture
IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION THE SHEATH WAS BROKEN OFF AND MISSING EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069578 ↗MalfunctionMay 8, 2025Degraded; Fracture; Degraded; Fracture
IT WAS REPORTED THAT THE PROBE TIPS ARE BREAKING OFF. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21986122 ↗MalfunctionMay 8, 2025Degraded; Fracture; Degraded; Fracture
IT WAS REPORTED THAT THE PROBE TIPS ARE BREAKING OFF. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21986120 ↗MalfunctionMay 8, 2025Degraded; Fracture; Degraded; Fracture
IT WAS REPORTED THAT THE PROBE TIPS ARE BREAKING OFF. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21985959 ↗MalfunctionApr 21, 2025Fracture; Fracture
IT WAS REPORTED BY THE TECHNICAL COMMENTS THAT THE CABLE IS STRETCHED AND RIPPED EXPOSING THE INTERNAL WIRES. THE SHEATH IS BROKEN OFF AND MISSING EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21874341 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page