Color Cuff 5921030235Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613154599431), received between Oct 12, 2018 and Jul 29, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (8 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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY WITH MENISCECTOMY SURGERY, THE DEVICE WOULD NOT INFLATE DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649695 ↗
• MalfunctionJul 22, 2025Leak/Splash

  WHEN WE WENT TO INFLATE THE TOURNIQUET, THE TOURNIQUET WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564385 ↗
• MalfunctionMar 23, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT BEFORE A PROCEDURE, THE TOURNIQUET CUFF WOULD NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600565 ↗
• MalfunctionMar 21, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE TOURNIQUET CUFF WAS LEAKING BEFORE 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 16584321 ↗
• MalfunctionMar 7, 2023Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16500407 ↗
• MalfunctionOct 25, 2022Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666695 ↗
• MalfunctionJul 27, 2020Gas/Air Leak; Gas/Air Leak

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD AN AIR LEAK. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10329677 ↗
• MalfunctionJan 7, 2020Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  THE USER FACILITY REPORTED THAT THE TOURNIQUET CUFF HAD HOLES AND WAS LEAKING DURING A PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT TOURNIQUET CUFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9559295 ↗
• MalfunctionOct 28, 2019Decrease in Pressure; Decrease in Pressure

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD A DECREASE IN PRESSURE. 1 EVENT HAD NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9245223 ↗
• MalfunctionJan 14, 2019Gas/Air Leak; Gas/Air Leak

  THE USER FACILITY REPORTED THAT THE STRYKER TOURNIQUET CUFF IS LEAKING DURING A PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT TOURNIQUET CUFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8246195 ↗
• MalfunctionOct 20, 2018Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO THE STRYKER SALES REPRESENTATIVE THAT THE TOURNIQUET BEGAN TO LEAK DURING A PROCEDURE. THERE WAS NO PATIENT IMPACT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7988047 ↗
• MalfunctionOct 12, 2018Decrease in Pressure; Decrease in Pressure

  THE USER FACILITY REPORTED TO THE STRYKER SALES REPRESENTATIVE THAT DURING A PROCEDURE THE DEVICE WOULD NOT KEEP PRESSURE AND AIR LEAKED OUT. THERE WAS NO PATIENT IMPACT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7962412 ↗
• MalfunctionOct 12, 2018Decrease in Pressure; Decrease in Pressure

  THE USER FACILITY REPORTED TO THE STRYKER SALES REPRESENTATIVE THAT DURING A PROCEDURE THE DEVICE WOULD NOT KEEP PRESSURE AND AIR LEAKED OUT. THERE WAS NO PATIENT IMPACT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7962410 ↗