N/A (REF 60-7075-105)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885825013936), received between Jun 18, 2025 and Aug 13, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Component Missing” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUSTOMER NOTICED A LEAKS IN THE CUFF AND ALARM/BEEPING OCCURRED WHEN USING THE CUFF. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793153 ↗
• MalfunctionAug 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUSTOMER NOTICED A LEAKS IN THE CUFF AND ALARM/BEEPING OCCURRED WHEN USING THE CUFF. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779212 ↗
• MalfunctionAug 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUSTOMER NOTICED A LEAKS IN THE CUFF AND ALARM/BEEPING OCCURRED WHEN USING THE CUFF. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779111 ↗
• MalfunctionAug 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUSTOMER NOTICED A LEAKS IN THE CUFF AND ALARM/BEEPING OCCURRED WHEN USING THE CUFF. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779110 ↗
• MalfunctionJun 18, 2025Component Missing; Expiration Date Error; No Apparent Adverse Event; Component Missing; Expiration Date Error; No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CASE OF TOURNIQUET CUFFS WITHOUT THE BLACK O-RING ON THE CONNECTING TUBE. AS REPORTED, THIS RESULTED IN THE CUFF NOT SEALING PROPERLY AND NOT PROPERLY INFLATING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287879 ↗
• MalfunctionJun 18, 2025Component Missing; Expiration Date Error; Component Missing; Expiration Date Error

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CASE OF TOURNIQUET CUFFS WITHOUT THE BLACK O-RING ON THE CONNECTING TUBE. AS REPORTED, THIS RESULTED IN THE CUFF NOT SEALING PROPERLY AND NOT PROPERLY INFLATING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287653 ↗
• MalfunctionJun 18, 2025Component Missing; Expiration Date Error; No Apparent Adverse Event; Component Missing; Expiration Date Error; No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CASE OF TOURNIQUET CUFFS WITHOUT THE BLACK O-RING ON THE CONNECTING TUBE. AS REPORTED, THIS RESULTED IN THE CUFF NOT SEALING PROPERLY AND NOT PROPERLY INFLATING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287649 ↗
• MalfunctionJun 18, 2025Component Missing; Expiration Date Error; No Apparent Adverse Event; Component Missing; Expiration Date Error; No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CASE OF TOURNIQUET CUFFS WITHOUT THE BLACK O-RING ON THE CONNECTING TUBE. AS REPORTED, THIS RESULTED IN THE CUFF NOT SEALING PROPERLY AND NOT PROPERLY INFLATING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287648 ↗
• MalfunctionJun 18, 2025Component Missing; Expiration Date Error; No Apparent Adverse Event; Component Missing; Expiration Date Error; No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CASE OF TOURNIQUET CUFFS WITHOUT THE BLACK O-RING ON THE CONNECTING TUBE. AS REPORTED, THIS RESULTED IN THE CUFF NOT SEALING PROPERLY AND NOT PROPERLY INFLATING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287647 ↗