N/A 60-7070-156-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024377202), received between Dec 13, 2022 and Jun 10, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING THE ASSEMBLY OF TRAYS, THE DEVICE HAD A DEBRIS INSIDE THE SEALED STERILE PACKAGE. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETED AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177160 ↗
• MalfunctionJun 10, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING THE ASSEMBLY OF TRAYS, THE DEVICE HAD A DEBRIS INSIDE THE SEALED STERILE PACKAGE. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETED AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177069 ↗
• MalfunctionDec 22, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHEN TURNING ON THE PRESSURE FOR THE ATS 4000, THE CUFF INFLATES AS NORMAL, BUT THE MACHINE NEEDS TO KEEP ADDING PRESSURE FOR THE ENTIRE PROCEDURE TO KEEP THE SUGGESTED PRESSURE FOR THIS PATIENT. THIS INDICATES THAT THERE IS A LEAK IN THE SINGLE USE CUFF. THE EVENT TIMING WAS DURING SURGERY. AN ALTERNATE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16034700 ↗
• MalfunctionDec 13, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING SURGERY WHEN TURNING ON THE PRESSURE FOR THE ATS 4000 THE CUFF INFLATES AS NORMAL, BUT THE MACHINE NEEDS TO KEEP ADDING PRESSURE FOR THE ENTIRE PROCEDURE TO KEEP THE SUGGESTED PRESSURE FOR THIS PATIENT. THIS INDICATES THAT THERE IS A LEAK IN THE SINGLE USE CUFF. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968453 ↗