N/A 60-7070-153-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024377172), received between Sep 15, 2022 and Nov 3, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THAT THE UNIT'S STERILE PACKAGE WAS LEAKING AIR. NO HARM OR INJURY WAS REPORTED AS THERE WERE NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066717 ↗
• MalfunctionSep 1, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT BEFORE SHIPMENT, DURING INSPECTION AT ARRIVAL FOUND DEBRIS IN STERILE PACKAGE. AT EVALUATION IT WAS FOUND TO NOT MEET SPECIFICATIONS. THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17669688 ↗
• MalfunctionOct 28, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PRODUCT DOESN'T HOLD THE PRESSURE AND ALL THE AIR IS GOING OUT SO THE PRODUCT DOESN'T FUNCTION. THE EVENT TIMING WAS DURING SURGERY PREP. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT. DELAY IS UNKNOWN. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15693221 ↗
• MalfunctionOct 28, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PRODUCT DOESN'T HOLD THE PRESSURE AND ALL THE AIR IS GOING OUT SO THE PRODUCT DOESN'T FUNCTION. THE EVENT TIMING WAS DURING SURGERY PREP. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT. DELAY IS UNKNOWN. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692856 ↗
• MalfunctionOct 28, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PRODUCT DOESN'T HOLD THE PRESSURE AND ALL THE AIR IS GOING OUT SO THE PRODUCT DOESN'T FUNCTION. THE EVENT TIMING WAS DURING SURGERY PREP. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT. DELAY IS UNKNOWN. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15691574 ↗
• MalfunctionSep 15, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF HAD AIR LEAKAGE. THE EVENT TIMING WAS DURING PREPARATION OF SURGERY. THERE IS 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 15430934 ↗