STRYKER 7400-009-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 07613327483055), received between Aug 30, 2022 and May 21, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (18 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Overheating of Device

  THE SALES REP FROM USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246432 ↗
• MalfunctionMay 14, 2026Overheating of Device

  No new information.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173266 ↗
• MalfunctionFeb 23, 2026Overheating of Device

  THE MANUFACTURER SALES REP REPORTED THAT THE DEVICE OVERHEATED DURING TESTING PRIOR TO A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24420526 ↗
• MalfunctionJan 8, 2026Detachment of Device or Device Component

  THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING COMPONENT WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005810 ↗
• MalfunctionAug 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE WAS MISSING COMPONENT WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903194 ↗
• MalfunctionJul 21, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556708 ↗
• MalfunctionJul 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE WAS MISSING SPRINGS WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435838 ↗
• MalfunctionJun 24, 2025Device Remains Activated; Device Remains Activated

  THE USER FROM USER FACILITY REPORTED THAT THE DEVICE WAS RUNNING CONTINUOUSLY DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318124 ↗
• MalfunctionJun 19, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS CONTINUOUSLY RUNNING (RUN-ON). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292595 ↗
• MalfunctionJun 19, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS CONTINUOUSLY RUNNING (RUN-ON). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292590 ↗
• MalfunctionJun 19, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS CONTINUOUSLY RUNNING (RUN-ON). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292474 ↗
• MalfunctionJun 19, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS CONTINUOUSLY RUNNING (RUN-ON). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292472 ↗
• MalfunctionJun 19, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS CONTINUOUSLY RUNNING (RUN-ON). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292418 ↗
• MalfunctionJun 19, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS CONTINUOUSLY RUNNING (RUN-ON). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292415 ↗
• MalfunctionJun 19, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS CONTINUOUSLY RUNNING (RUN-ON). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292328 ↗
• MalfunctionJun 19, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS CONTINUOUSLY RUNNING (RUN-ON). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292324 ↗
• MalfunctionJun 19, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS CONTINUOUSLY RUNNING (RUN-ON). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289392 ↗
• MalfunctionJun 19, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS CONTINUOUSLY RUNNING (RUN-ON). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289391 ↗
• MalfunctionJun 19, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS CONTINUOUSLY RUNNING (RUN-ON). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289390 ↗
• MalfunctionJun 19, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS CONTINUOUSLY RUNNING (RUN-ON). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289389 ↗
• MalfunctionJun 19, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS CONTINUOUSLY RUNNING (RUN-ON). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289388 ↗
• MalfunctionJun 17, 2025Device Remains Activated; Device Remains Activated

  THE USER FROM USER FACILITY REPORTED THAT THE DEVICE CONTINUED TO RUN (RUN-ON) DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235435 ↗
• MalfunctionJun 17, 2025Device Remains Activated; Device Remains Activated

  THE USER FROM USER FACILITY REPORTED THAT THE DEVICE CONTINUED TO RUN (RUN-ON) DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235179 ↗
• MalfunctionMar 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING BALL PLUNGER WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21539950 ↗
• MalfunctionMar 5, 2025Device Remains Activated; Device Remains Activated

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD RUN ON WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21524790 ↗