NA 6000-074-000Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · SHUNT PLACEMENT TOOL L 2-4 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540469991), received between Apr 10, 2017 and Jan 19, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Imprecision” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Imprecision2
- Deformation Due to Compressive Stress1
- Disassembly1
- Incorrect Measurement1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2024Imprecision; Incorrect, Inadequate or Imprecise Result or Readings; Imprecision; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE ACCURACY OF A SHUNT PLACEMENT TOOL WAS "OFF" DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18544810 ↗MalfunctionApr 20, 2022Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement
PER THE CUSTOMER, THE DEVICE WAS NOT ACCURATE DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14161747 ↗MalfunctionSep 12, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE TOOL WAS BENT DURING CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7870446 ↗MalfunctionApr 10, 2017Disassembly; Disassembly
IT WAS REPORTED THAT A PIECE OF THE DEVICE DISASSEMBLED AT THE USER FACILITY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE ONGOING.
Patient problems: No Information
MAUDE report 6477649 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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