Equalizer™ M001171100Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729402404), received between Feb 17, 2019 and Nov 6, 2025 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (12 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE BALLOON MIGRATED, AND PATIENT COMPLICATIONS OCCURRED. A 33MM 100CM EQUALIZER BALLOON WAS SELECTED FOR AN ORGAN PROCUREMENT. THE DEVICE WAS POSITIONED AT THE LEVEL OF THE SUPRA-DIAPHRAGMATIC ABDOMINAL AORTA. THE DEVICE MIGRATED TO THE LEVEL OF THE THORACIC AORTA, THEN TO THE LEFT VENTRICLE. CONSEQUENTLY, THE PROCEDURE WAS STOPPED. IT WAS REPORTED THAT LOSS OF LIVER AND KIDNEY GRAFTS OCCURRED.

  Patient problems: Embolism/Embolus; Ischemia

  MAUDE report 23490812 ↗
• MalfunctionAug 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURE OCCURRED. A 33/7/2/100 EQUALIZER BALLOON CATHETER WAS SELECTED FOR USE. WHILE ATTEMPTING TO USE THE BALLOON CATHETER, THE PHYSICIAN REPORTED THAT THE BALLOON HAD BURST PRIOR TO THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841611 ↗
• InjuryMay 28, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE BALLOON MOBILIZED, AND PATIENT COMPLICATIONS OCCURRED. A 33MM 100CM EQUALIZER BALLOON WAS SELECTED FOR AN ORGAN PROCUREMENT. AFTER INFLATION OF THE BALLOON IN THE DESCENDING THORACIC AORTA, THE CARDIOPULMONARY BYPASS (CPB) DECREASED. THE BALLOON MOBILIZED SPONTANEOUSLY AND ROSE TO THE ASCENDING AORTA. CONSEQUENTLY, THE PROCEDURE WAS STOPPED. IT WAS REPORTED THAT LOSS OF LIVER AND KIDNEY GRAFTS OCCURRED.

  Patient problems: Embolism/Embolus; Ischemia

  MAUDE report 22096000 ↗
• InjuryOct 21, 2024Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT A BALLOON DEFLATION FAILURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A 33/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE DEVICE EXPERIENCED A DEFLATION FAILURE, MAKING IT DIFFICULT TO REMOVE. A NON-BSC GUIDEWIRE WAS DELIBERATELY USED TO RUPTURE THE BALLOON AND FACILITATE ITS REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20496740 ↗
• MalfunctionAug 28, 2023Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND DETACHMENT OCCURRED. A NON-BSC INTRODUCER SHEATH WAS INSERTED. AFTER IT WAS INTRODUCED, A 33/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON BURST. UPON REMOVAL OF THE DEVICE, A TEAR AT THE ENDS PRACTICALLY DETACHED FROM THE CATHETER. THE PHYSICIAN COMPLETELY REMOVED AND ANOTHER EQUALIZER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633791 ↗
• MalfunctionMay 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ABDOMINAL AORTA. A 33/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE DILUTED CONTRAST AGENT WAS INJECTED INTO THE BALLOON DURING INITIAL INFLATION FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947890 ↗
• MalfunctionSep 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 33/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15458548 ↗
• MalfunctionJun 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN ABDOMINAL AORTA. A 33/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 5 SECONDS, THE BALLOON WAS RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14672909 ↗
• MalfunctionJan 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED AORTA. A 33/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 19 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13195534 ↗
• MalfunctionMay 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 33MM X 100CM (7F) EQUALIZER BALLOON WAS SELECTED FOR USE IN A BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION (BRTO) PROCEDURE. THE BALLOON WAS ADVANCED INTO THE RENAL VEIN AND INFLATED TO NOMINAL PRESSURE, VOLUME INSIDE THE BALLOON WAS LESS THAN 19CC. AFTER A FEW SECONDS, THE BALLOON RUPTURED AND SALINE LEAKED. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776921 ↗
• MalfunctionAug 4, 2020Deflation Problem; Obstruction of Flow; Deflation Problem; Obstruction of Flow

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE OCCURRED. A 33/7/2/100MM EQUALIZER BALLOON CATHETER WAS ADVANCED AND INFLATED FOR DILATATION. HOWEVER, THE BALLOON COULD NOT BE DEFLATED DESPITE SEVERAL ATTEMPTS USING A SYRINGE. SUBSEQUENTLY, NEGATIVE PRESSURE WAS APPLIED SEVERAL TIMES BUT THE BALLOON STILL FAILED TO DEFLATE. AFTER A WHILE, NEGATIVE PRESSURE WAS AGAIN APPLIED AND THE BALLOON WAS DEFLATED. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS REPORTED. THE PHYSICIAN NOTED THAT IT SEEMED THE INFLATION LUMEN GOT BLOCKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10363379 ↗
• 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 9865324 ↗
• 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 9865323 ↗
• MalfunctionMar 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 33/7/2/100 EQUALIZER BALLOON WAS SELECTED FOR USE FOR AN AORTIC ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE WITH MILD TORTUOSITY. DURING THE PROCEDURE, THE BALLOON RUPTURED WHEN SLIGHT PRESSURE WAS APPLIED WITH A SYRINGE. THE DEVICE WAS REMOVED FROM THE PATIENT WITH NO ISSUES. A SECOND 33/7/2/100 EQUALIZER BALLOON WAS USED, BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRD EQUALIZER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9848340 ↗
• MalfunctionMar 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 33/7/2/100 EQUALIZER BALLOON WAS SELECTED FOR USE FOR AN AORTIC ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE WITH MILD TORTUOSITY. DURING THE PROCEDURE, THE BALLOON RUPTURED WHEN SLIGHT PRESSURE WAS APPLIED WITH A SYRINGE. THE DEVICE WAS REMOVED FROM THE PATIENT WITH NO ISSUES. A SECOND 33/7/2/100 EQUALIZER BALLOON WAS USED, BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRD EQUALIZER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9848338 ↗
• MalfunctionDec 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 33/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION, THE BALLOON RUPTURED. 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 9448441 ↗
• MalfunctionSep 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED AORTA. A 33/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR ENDOVASCULAR ANEURYSM REPAIR (EVAR) APPOSITION. HOWEVER, ON INITIAL INFLATION AT 2 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9126976 ↗
• MalfunctionFeb 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ANEURYSM IN THE THORACIC AORTA. FOLLOWING STENT GRAFT PLACEMENT, A 33/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, UPON INITIAL INFLATION, THE BALLOON RUPTURED. 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 8346569 ↗