Equalizer™ M001171090Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729402398), received between Aug 15, 2018 and Nov 19, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. AN EQUALIZER BALLOON CATHETER WAS SELECTED FOR USE DURING AN AORTIC STENT GRAFT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE BALLOON RUPTURED. TWO ADDITIONAL BALLOONS WERE USED WHICH RESULTED IN EXTENDED PROCEDURE TIME. THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594895 ↗
• MalfunctionApr 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. AN EQUALIZER BALLON WAS SELECTED FOR A PROCEDURE. DURING THE PROCEDURE, HOWEVER, THE BALLOON BURST. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176983 ↗
• MalfunctionApr 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. AN EQUALIZER BALLON WAS SELECTED FOR A PROCEDURE. DURING THE PROCEDURE, HOWEVER, THE BALLOON BURST. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176962 ↗
• MalfunctionApr 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. AN EQUALIZER BALLON WAS SELECTED FOR A PROCEDURE. DURING THE PROCEDURE, HOWEVER, THE BALLOON BURST. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176848 ↗
• MalfunctionApr 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. AN EQUALIZER BALLON WAS SELECTED FOR A PROCEDURE. DURING THE PROCEDURE, HOWEVER, THE BALLOON BURST. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163239 ↗
• MalfunctionApr 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. AN EQUALIZER BALLOON WAS SELECTED FOR AN AORTIC STENT DEPLOYMENT PROCEDURE. DURING THE PROCEDURE, HOWEVER, THE BALLOON BURST. ANOTHER EQUALIZER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19089832 ↗
• MalfunctionFeb 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT TWO EQUALIZER BALLOONS RUPTURED DURING AORTIC STENT PLACEMENT. A EQUALIZER OCCLUSION BALLOON CATHETER WAS CHOSEN TO ASSIST WITH TREATMENT FOR PERCUTANEOUS AORTO-BI-ILIAC STENTING OF AN ABDOMINAL AORTIC ANEURYSM. AN ARTERIOGRAPHY WAS PERFORMED TO LOCATE THE RENAL ARTERIES, AND THE STENT WAS GRADUALLY DEPLOYED. THE STENT DEPLOYMENT WAS COMPLETED FROM THE RIGHT SIDE TO THE EXTERNAL ILIAC SINCE THE RIGHT HYPOGASTRIC WAS OCCLUDED. DURING DEPLOYMENT OF THE AORTIC STENT, THE EQUALIZER BALLOON RUPTURED. ANOTHER EQUALIZER BALLOON WAS USED; HOWEVER, THAT BALLOON ALSO RUPTURED. THERE WERE NO PATIENT COMPLICATIONS OR ADDITIONAL INTERVENTION NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639376 ↗
• MalfunctionFeb 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT TWO EQUALIZER BALLOONS RUPTURED DURING AORTIC STENT PLACEMENT. AN EQUALIZER OCCLUSION BALLOON CATHETER WAS CHOSEN TO ASSIST WITH TREATMENT FOR PERCUTANEOUS AORTO-BI-ILIAC STENTING OF AN ABDOMINAL AORTIC ANEURYSM. AN ARTERIOGRAPHY WAS PERFORMED TO LOCATE THE RENAL ARTERIES, AND THE STENT WAS GRADUALLY DEPLOYED. THE STENT DEPLOYMENT WAS COMPLETED FROM THE RIGHT SIDE TO THE EXTERNAL ILIAC SINCE THE RIGHT HYPOGASTRIC WAS OCCLUDED. DURING DEPLOYMENT OF THE AORTIC STENT, THE EQUALIZER BALLOON RUPTURED. ANOTHER EQUALIZER BALLOON WAS USED; HOWEVER, THAT BALLOON ALSO RUPTURED. THERE WERE NO PATIENT COMPLICATIONS OR ADDITIONAL INTERVENTION NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639337 ↗
• MalfunctionOct 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED ABDOMINAL AORTA. A 33/7/2/65 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15525647 ↗
• MalfunctionJul 16, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A 33/7/2/65 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON THE SECOND INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8794717 ↗
• MalfunctionJan 8, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS ABDOMINAL AORTA. A 33/7/2/65 EQUALIZER BALLOON CATHETER WAS ADVANCED TO THE STENT GRAFT. HOWEVER, WHEN TOUCH-UP WAS PERFORMED INSIDE THE STENT GRAFT, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8228272 ↗
• MalfunctionNov 7, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AORTA. A 33/7/2/65 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, THE BALLOON RUPTURED IMMEDIATELY AFTER THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8046347 ↗
• MalfunctionAug 15, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ABDOMINAL AORTA. AFTER DEPLOYMENT OF A NON-BSC STENT, A 33/7/2/65MM EQUALIZER BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FORM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7786132 ↗