RUSCH IPN046435Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14026704589958), received between Aug 15, 2022 and Apr 27, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THERE WAS A SEPARATION BETWEEN THE GRAY SECUREMENT PIECE AND THE FLEXIBLE SILICONE PIECE INSIDE, SO THE EZ-BLOCKER WAS NOT PROPERLY SECURED TO THE MULTIPORT ADAPTER. AS A RESULT, THE DEVICE WAS DISLODGED MID-CASE. THE ISSUE WAS RESOLVED BY ISOLATING THE LUNG AGAIN AND REPOSITIONING THE EZ-BLOCKER. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16825878 ↗
• MalfunctionApr 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THERE WAS A SEPARATION BETWEEN THE GRAY SECUREMENT PIECE AND THE FLEXIBLE SILICONE PIECE INSIDE, SO THE EZ-BLOCKER WAS NOT PROPERLY SECURED TO THE MULTIPORT ADAPTER. AS A RESULT, THE DEVICE WAS DISLODGED MID-CASE. THE ISSUE WAS RESOLVED BY ISOLATING THE LUNG AGAIN AND REPOSITIONING THE EZ-BLOCKER. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16825822 ↗
• MalfunctionSep 26, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE: "EZ BLOCKER BALLOONS WERE INDEPENDENTLY INFLATING AND/OR DEFLATING ON THEIR OWN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15484450 ↗
• MalfunctionSep 19, 2022Leak/Splash; Leak/Splash

  COMPLAINT REPORTS THAT: DISTAL BALLOONS ARE INDEPENDENTLY DEFLATING, AND INFLATING. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15447500 ↗
• MalfunctionAug 15, 2022Leak/Splash; Leak/Splash

  THE COMPLAINTS REPORTS THAT: "THE BALLOON INFLATES BUT LEAKS OUT RATHER QUICKLY". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15224020 ↗