Equalizer™ M001171080Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729402381), received between Oct 16, 2019 and Oct 24, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DIFFICULTIES WITH DEFLATION OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS ABDOMINAL AORTA. A 27/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON HAS DIFFICULTY DEFLATING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20528085 ↗
• MalfunctionApr 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 27/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725697 ↗
• MalfunctionMar 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 27/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541922 ↗
• MalfunctionDec 15, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN A STENT GRAFT IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC ARTERY AND EXTERNAL ARTERY. A 27/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE DEVICE WAS USED WITH A 20 CC SYRINGE FOR THE TOUCH-UP, SMOOTH DEFLATION COULD NOT BE PERFORMED. SUBSEQUENTLY, THE 20 CC SYRINGE WAS REPLACED WITH A NEW ONE WHERE NEGATIVE PRESSURE WAS APPLIED AND DEFLATION WAS PERFORMED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010047 ↗
• MalfunctionNov 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 27/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12884920 ↗
• MalfunctionOct 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 27/7/2/100 EQUALIZER BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10703656 ↗
• MalfunctionJul 13, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE. A 27/7/2/100 EQUALIZER BALLOON WAS SELECTED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. DURING THE PROCEDURE, IT WAS NOT POSSIBLE TO DEFLATE THE BALLOON. THE DEVICE WAS CUT IN ORDER TO BE REMOVED FROM THE PATIENT'S ARTERY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10264400 ↗
• MalfunctionMar 23, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS AORTA-ILIAC. DURING THE PROCEDURE, AN EQUALIZER 33/7/2/100 BALLOON CATHETER WAS ADVANCED FOR DILATATION. AFTER THE STENT GRAFT WAS PLACED, TOUCH-UP WAS PERFORMED WITHOUT A PROBLEM FROM THE AORTA TO THE LEG FROM THE LEFT SIDE FEMORAL. NEXT, AFTER DILATION WAS PERFORMED, WHEN TOUCH-UP WAS PERFORMED FROM THE RIGHT SIDE FEMORAL WITH THE USE OF THE SAME BALLOON, NEGATIVE PRESSURE WAS APPLIED, BUT DEFLATION COULD NOT BE PERFORMED. THE 20CC SYRINGE WAS CHANGED TO 10CC SYRINGE IN FIRST INFLATION AND WAS ABLE TO PERFORM THE DEFLATION SLOWLY FOR FOUR TO FIVE MINUTES MANUALLY AND SALINE CONTRAST RATIO WAS APPROXIMATELY 50:50. THIS WAS ATTEMPTED THREE TIMES USING THE SAME SIZE, 33MM, AND 27MM ALL HAD THE SAME ISSUE. EVENTUALLY, TOUCH-UP WAS PERFORMED USING GORES CODA BALLOON AND WAS ABLE TO DEFLATE WITH NO RESISTANCE FELT. THE CAUSE WAS NOT CONFIRMED SINCE THE BLOOD VESSEL WAS RELATIVELY STRAIGHT ANATOMICALLY. MOREOVER, THERE SHOULD BE NO RESISTANCE FELT SINCE THE SHEATH WAS FOR STENT GRAFT AND THE LUMEN WAS THICK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9865325 ↗
• MalfunctionDec 2, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTIC ANEURYSM. A 27/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN DILATATION WAS PERFORMED INSIDE THE GRAFT, THE BALLOON RUPTURED. THE DEVICE WAS SIMPLY REMOVED AND COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9396571 ↗
• MalfunctionOct 16, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED AORTA. A 27/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED AND INFLATED FOR DILATATION. HOWEVER, UPON DEFLATION, THE BALLOON DEPRESSURIZED BUT COULD NOT BE DEFLATED. THE DEVICE WAS PULLED INSIDE THE SHEATH AND WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9196788 ↗