EqualizerRecalls & reported problems across all models
Boston Scientific Corporation · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 50
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 7 models of Equalizer by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Aug 15, 2018 and Nov 19, 2025 — classified as 4 injuries, 46 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (37 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Equalizer problems
Device problems
- Material Rupture37
- Deflation Problem9
- Difficult to Remove3
- Detachment of Device or Device Component2
- Failure to Deflate2
- Positioning Problem2
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient20
- No Known Impact Or Consequence To Patient4
- Embolism/Embolus2
- Ischemia2
- Device Embedded In Tissue or Plaque1
Equalizer models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Equalizer™ M001171100Catheter, intravascular occluding, temporary18 reports
- Equalizer™ M001171090Catheter, intravascular occluding, temporary13 reports
- Equalizer™ M001171080Catheter, intravascular occluding, temporary10 reports
- Equalizer™ M001171120Catheter, intravascular occluding, temporary6 reports
- Equalizer™ M001171060Catheter, intravascular occluding, temporary1 report
- Equalizer™ M001171070Catheter, intravascular occluding, temporary1 report
- Equalizer™ M001171110Catheter, intravascular occluding, temporary1 report
Recent Equalizer adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗MalfunctionJun 16, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A BALLOON BURST OCCURRED. AN EQUALIZER BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17144577 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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