Color Cuff 5921018235Recalls & reported problems
Stryker Corporation · Disposable Tourniquet Cuff Single Bladder, Dual Port and Quick Connect Connector · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07613154599295), received between Feb 12, 2025 and Jun 11, 2025 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Decrease in Pressure” (20 reports).
2 FDA recall records name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Jul 2, 2025Open, Classified
Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.
Z-2277-2025 · Root cause: Equipment maintenance · FDA record ↗
- Nov 6, 2019Terminated
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
Z-0593-2020 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Decrease in Pressure20
Patient problems
- No Clinical Signs, Symptoms or Conditions20
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2025Decrease in Pressure; Decrease in Pressure
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22183233 ↗MalfunctionMay 6, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY THE DEVICE WOULD NOT INFLATE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21967282 ↗MalfunctionMar 24, 2025Decrease in Pressure; Decrease in Pressure
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21676341 ↗MalfunctionMar 24, 2025Decrease in Pressure; Decrease in Pressure
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21676248 ↗MalfunctionMar 24, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS LEAKING PRESSURE 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 21676219 ↗MalfunctionMar 24, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS LEAKING PRESSURE 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 21676161 ↗MalfunctionMar 24, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS LEAKING PRESSURE 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 21676053 ↗MalfunctionMar 24, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS LEAKING PRESSURE 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 21676047 ↗MalfunctionFeb 26, 2025Decrease in Pressure; Decrease in Pressure
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21471426 ↗MalfunctionFeb 26, 2025Decrease in Pressure; Decrease in Pressure
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21471140 ↗MalfunctionFeb 26, 2025Decrease in Pressure; Decrease in Pressure
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470362 ↗MalfunctionFeb 26, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS NOT HOLDING PRESSURE AND LEAKING AIR 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 21470243 ↗MalfunctionFeb 26, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS LEAKING PRESSURE 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 21470083 ↗MalfunctionFeb 26, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS LEAKING PRESSURE 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 21470082 ↗MalfunctionFeb 26, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS LEAKING PRESSURE 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 21470081 ↗MalfunctionFeb 26, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS LEAKING PRESSURE 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 21470078 ↗MalfunctionFeb 25, 2025Decrease in Pressure; Decrease in Pressure
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21463008 ↗MalfunctionFeb 25, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS NOT HOLDING PRESSURE 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 21461024 ↗MalfunctionFeb 12, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS NOT HOLDING PRESSURE 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 21364668 ↗MalfunctionFeb 12, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE DEVICE IS NOT HOLDING PRESSURE 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 21364667 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.