CORE, MaestroRecalls & reported problems across all models
Stryker Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 130
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 4 models of CORE, Maestro by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 130 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2018 and Jul 29, 2025 — classified as 130 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (34 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 CORE, Maestro problems
Device problems
- Fluid/Blood Leak34
- Overheating of Device27
- Leak/Splash19
- Detachment of Device or Device Component14
- Unintended Power Up12
- Burst Container or Vessel8
- Fail-Safe Problem7
- Physical Resistance/Sticking7
Patient problems
- No Clinical Signs, Symptoms or Conditions75
- No Patient Involvement46
- No Known Impact Or Consequence To Patient14
- No Consequences Or Impact To Patient11
- No Information2
- Superficial (First Degree) Burn1
CORE, Maestro models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CORE, Maestro 5400200000MOTOR, DRILL, PNEUMATIC75 reports
- CORE, Maestro 5400201000MOTOR, DRILL, PNEUMATIC45 reports
- CORE, Maestro 5400218000MOTOR, DRILL, PNEUMATIC8 reports
- CORE, Maestro 5400207000MOTOR, DRILL, PNEUMATIC2 reports
Recent CORE, Maestro adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FAIL-SAFE DID NOT OPERATE. 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22646519 ↗MalfunctionJul 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN APRIL 1 ¿ JUNE 30, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FLUID/BLOOD LEAK. - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22587156 ↗MalfunctionApr 21, 2025Fail-Safe Problem; Fail-Safe Problem
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE EXPERIENCED A FAIL-SAFE PROBLEM THAT COULD RESULT IN UNINTENDED ACTIVATION. - 2 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21876261 ↗MalfunctionJan 22, 2025Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 2 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE. -THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21207553 ↗MalfunctionJan 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. 6 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21201045 ↗MalfunctionOct 22, 2024Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 3 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20501734 ↗MalfunctionOct 21, 2024Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. 2 EVENTS HAD NO PATIENT INVOLVEMENT: NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20497323 ↗MalfunctionJul 24, 2024Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 5 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19823134 ↗MalfunctionJul 24, 2024Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING.1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19822901 ↗MalfunctionApr 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES (B)(4) MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. - (B)(4) EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19113446 ↗MalfunctionJan 22, 2024Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. - 5 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18557630 ↗MalfunctionJan 22, 2024Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18557283 ↗MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18556851 ↗MalfunctionOct 23, 2023Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 8 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 8 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17993049 ↗MalfunctionOct 23, 2023Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17987483 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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