RUSCH IPN913391Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10801902142372), received between Feb 23, 2021 and Aug 10, 2023 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "LEAKAGE DURING USE. DURING THE PROCEDURE, THE BALLOONS SEEMED TO DEFLATE SLOWLY. AS A RESULT, THE LUNG GRADUALLY CAME UP DURING THE OPERATION. A TUBE THAT IS AT LEAST 0.5 SIZE LARGER IS ALWAYS USED." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17497256 ↗
• MalfunctionAug 9, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "LEAKAGE DURING USE. DURING THE PROCEDURE, THE BALLOONS SEEMED TO DEFLATE SLOWLY. AS A RESULT, THE LUNG GRADUALLY CAME UP DURING THE OPERATION. A TUBE THAT IS AT LEAST 0.5 SIZE LARGER IS ALWAYS USED." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17494260 ↗
• MalfunctionAug 9, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "LEAKAGE DURING USE. DURING THE PROCEDURE, THE BALLOONS SEEMED TO DEFLATE SLOWLY. AS A RESULT, THE LUNG GRADUALLY CAME UP DURING THE OPERATION. A TUBE THAT IS AT LEAST 0.5 SIZE LARGER IS ALWAYS USED." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17494253 ↗
• MalfunctionAug 8, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, "BOTH THE CUFFS ARE GETTING INFLATED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS OR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17479591 ↗
• MalfunctionApr 6, 2023Deflation Problem; Deflation Problem

  REPORTED ISSUE: DURING A VATS PROCEDURE WITH A 14-YEAR-OLD, 151CM, 38KG, MALE PATIENT THE SUCTION CATHETER WAS BEING USED CONTINUOUSLY. CASE STARTED WITH APPROPRIATE POSITIONING OF EZ BLOCKER UNDER VISION AND ISOLATION OF RIGHT LUNG WITH 6 CC AIR - FOLLOWED BY DEFLATING THE LUNG. PERI PROCEDURE, RIGHT LUNG STARTED VENTILATING PARTIALLY AND HENCE 2 CC AIR WAS ADDED IN THE CUFF. AFTER AN HOUR, THE LUNG STARTED GETTING VENTILATION AGAIN AND GOT INFLATED SLOWLY. THE ANESTHETIST VERIFIED THE CUFF POSITION AND ITS INFLATION BY FOB. ALTHOUGH EZB APPEARED FINE BUT LUNG ISOLATION WAS NOT POSSIBLE.

  Patient problems: Insufficient Information

  MAUDE report 16694462 ↗
• MalfunctionDec 5, 2022Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE BALLOON WAS DEFECTIVE DURING USE. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15914808 ↗
• InjuryOct 3, 2022Leak/Splash; Leak/Splash

  THE COMPLAINT REPORTED THAT: "WE INFLATED THE GREEN BALLOON TO ISOLATE THE RIGHT MAINSTEM. DURING THE CASE, RIGHT UPPER LOBE BEGIN TO INFLATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527273 ↗
• MalfunctionSep 26, 2022Leak/Splash; Leak/Splash

  THE COMPLAINT REPORTS THAT: "EZ BLOCKER BALLOONS BOTH INDEPENDENTLY INFLATING AND/OR DEFLATING ON THEIR OWN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15484461 ↗
• MalfunctionSep 26, 2022Leak/Splash; Leak/Splash

  THE COMPLAINT REPORTS THAT: "EZ BLOCKER BALLOONS BOTH INDEPENDENTLY INFLATING AND/OR DEFLATING ON THEIR OWN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15484457 ↗
• MalfunctionAug 9, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT "DURING USES THE BRONCHEAL CUFF (YELLOW CUFF) WHICH IS NOT INFLATED IS GETTING AUTO INFLATED AFTER SOME TIME."

  Patient problems: Insufficient Information

  MAUDE report 15192801 ↗
• MalfunctionDec 27, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "CUSTOMER FOUND THAT THERE WAS A LEAKAGE WHEN CONNECTING EZ-MULTIPORT TO BREATHING CIRCUIT. IT WAS CONFIRMED THAT DEFECT WAS FOUND BEFORE PATIENT USE". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087406 ↗
• MalfunctionOct 6, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED "DOCTOR TRIED TO INFLATE YELLOW BALLOON ONLY, BUT BLUE BALLOON ALSO GOT INFLATED". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583612 ↗
• MalfunctionJul 29, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "PRIOR TO USE ON PATIENT, THE CUSTOMER DID FUNCTIONAL TEST AND FOUND BALLOON LEAKAGE". NO PATIENT INVOLVEMENT R EPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246240 ↗
• MalfunctionJul 6, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT" PRIOR TO USE ON PATIENT, THE CUSTOMER DID FUNCTIONAL TEST AND FOUND BALLOON LEAKAGE". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12124354 ↗
• MalfunctionMay 14, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED "DR. D'ATTELLIS INFLATES ONE CUFF AND FINDS THAT OVER TIME THE OTHER BALLOON GRADUALLY INFLATES. USES 100% OXYGEN, NO NITROUS OXIDE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11828256 ↗
• MalfunctionApr 26, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED "WE HAD AN ISSUE WITH ONE OF THE BLOCKERS WHEN WE INFLATE ONE OVER TIME THE OTHER ALSO INFLATED". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: Decreased Peak Expiratory Flow rate

  MAUDE report 11723208 ↗
• MalfunctionMar 29, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "EZ BLOCKER BRONCHIAL BLOCKER SIZE 7 FR WAS FOUND WITH YELLOW CUFF LEAKING DURING PROCEDURE". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11584688 ↗
• MalfunctionMar 22, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED "END USER REPORTED THAT WHILE THE GOAL OF THE BLOCKER IS TO ONLY HAVE 1 CUFF INFLATED TO ISOLATE, THEY WERE UNABLE TO DO SO POTENTIAL TO BE USER ERROR AS THE LUMENS TO INFLATE THE CUFFS ARE INDEPENDENT OF EACH OTHER SO INFLATING ONE WOULD NOT EFFECT THE OTHER BEING INFLATED OR NOT. IT WAS NOT POSSIBLE TO HAVE ONLY ONE OF THE BALLOONS INFLATED". NO PATIENT INJURY OR HARM REPORTED. ADDITIONAL DEVICE WAS USED. UNKNOWN PATIENT CONDITION AT TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11546607 ↗
• MalfunctionFeb 23, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED "THAT THE LEFT CUFF OF THE DEVICE WAS INFLATED BY THE USER. DURING USE THIS LEFT CUFF DEFLATED AND AT THE SAME TIME THE RIGHT CUFF (WHICH WAS NOT INFLATED BY THE USER) DID INFLATE AUTOMATICALLY". NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364999 ↗
• MalfunctionFeb 23, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED "THAT THE LEFT CUFF OF THE DEVICE WAS INFLATED BY THE USER. DURING USE THIS LEFT CUFF DEFLATED AND AT THE SAME TIME THE RIGHT CUFF (WHICH WAS NOT INFLATED BY THE USER) DID INFLATE AUTOMATICALLY". NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364987 ↗