XXL VascularRecalls & reported problems across all models

We found 8 models of XXL Vascular by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 116 adverse event reports in the FDA's MAUDE database, received between Aug 20, 2018 and Dec 1, 2025 — classified as 14 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (99 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

Most reported XXL Vascular problems

XXL Vascular models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• XXL™ Vascular M001145140

  Catheter, angioplasty, peripheral, transluminal
  51 reports
• XXL™ Vascular M001145320

  Catheter, angioplasty, peripheral, transluminal
  41 reports
• XXL™ Vascular M001145150

  Catheter, angioplasty, peripheral, transluminal
  8 reports
• XXL™ Vascular M001145100

  Catheter, angioplasty, peripheral, transluminal
  6 reports
• XXL™ Vascular M001145120

  Catheter, angioplasty, peripheral, transluminal
  6 reports
• XXL™ Vascular M001145300

  Catheter, angioplasty, peripheral, transluminal
  2 reports
• XXL™ Vascular M001145110

  Catheter, angioplasty, peripheral, transluminal
  1 report
• XXL™ Vascular M001145130

  Catheter, angioplasty, peripheral, transluminal
  1 report

Recent XXL Vascular adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BALLOON LEAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. DURING THE PROCEDURE, ROUTINE LEFT FEMORAL VEIN PUNCTURE WITH A 10F SHEATH WAS PERFORMED. THE GUIDEWIRE AND CATHETER WERE ADVANCED THROUGH THE STENOTIC SEGMENT OF THE LEFT ILIAC VEIN, AND THE GUIDEWIRE ENTERED THE INFERIOR VENA CAVA. A /14-6/5.8/75 XXL WAS FLUSHED AND DELIVERED INTO THE BODY. HOWEVER, UPON BALLOON DILATATION USING A PRESSURED PUMP, A CONTRAST EXTRAVASATION WAS NOTED. UPON WITHDRAWAL, IT WAS NOTED THAT THE BALLOON WAS LEAKING LIQUID, AND IT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED USING A XXL 14 * 60 BALLOON CATHETER. THERE WERE NO COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR IDENTIFIED IN THE BALLOON MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678632 ↗
• MalfunctionNov 21, 2025Inflation Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON HOLE OCCURRED. A 14-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, WHEN ATTEMPTED TO INFLATE THE BALLOON, IT DID NOT INFLATE. THE DEVICE WAS REMOVED, AND IT WAS NOTED THAT THERE WAS A HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617170 ↗
• MalfunctionNov 12, 2025Difficult to Remove; Material Rupture; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BALLOON BURST AND BECAME ENTANGLED WITH THE TIP OF THE SHEATH. A 14-4/5.8/75 XXL BALLOON CATHETER WAS USED TO TREAT STENOSIS OF THE CENTRAL VEIN IDENTIFIED AFTER ARTERIOVENOUS FISTULA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (AVF PTA) PROCEDURE. HOWEVER, AFTER POSITIONING THE PRODUCT ON THE LESION AND INCREASING PRESSURE TO THE NOMINAL LEVEL, THE BALLOON BURST, CAUSING CONTRAST AGENT LEAKAGE. DURING WITHDRAWAL, THE BALLOON BECAME ENTANGLED WITH THE TIP OF THE SHEATH AND WAS UNABLE TO BE REMOVED. AS A RESULT, THE CATHETER WAS CUT AND REMOVED ALONG WITH THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536556 ↗
• MalfunctionSep 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED CENTRAL VEIN. A 14-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON BURST DURING THE FIRST INFLATION BEFORE THE RATED BURST PRESSURE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935107 ↗
• MalfunctionAug 29, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE BALLOON HAD A PINHOLE. A 14-2/5.8/120 XXL VASCULAR BALLOON WAS SELECTED FOR A PROCEDURE TO TREAT AN OCCLUSION. DURING THE PROCEDURE, THE DEVICE WAS INSERTED AND AS THE BALLOON WAS INFLATED, IT DID NOT HOLD THE PRESSURE. THE DEVICE WAS REMOVED, AND IT WAS OBSERVED THAT THE BALLOON HAD A PINHOLE THAT LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER XXL VASCULAR BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923321 ↗
• MalfunctionAug 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED RIGHT COMMON ILIAC VEIN. A 6/5.8/75 XXL BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS ADVANCED PROXIMAL TO THE TOP OF THE STENT OVER A 0.035 AMPLATZ WIRE. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 5 ATMOSPHERES FOR 5 SECONDS. UPON DEFLATION, BLOOD WAS OBSERVED RETURNING INTO THE INDEFLATOR. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898362 ↗
• MalfunctionJul 24, 2025Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Material Rupture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE AND TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE VASCULAR ARTERY. A /14-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED WHILE BEING INFLATED WITHIN THE NOMINAL TO RATED PRESSURE RANGE. THE BALLOON WAS THEN REMOVED, AND IT WAS OBSERVED THAT THE TIP PORTION HAD SEPARATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588858 ↗
• MalfunctionJul 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT EXTERNAL ILIAC ARTERY. A 14-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS CONTINUED WITH THE ORIGINAL METHOD AND COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523192 ↗
• MalfunctionApr 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. PATIENT WAS PRESENTED WITH MAY THURNER'S. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED COMMON ILIAC ARTERY. AFTER GAINING POPLITEAL ACCESS WITH A 9FR SHEATH, AN AMPLATZ WIRE WAS ADVANCED FOLLOWED BY PLACING A NON-BOSTON SCIENTIFIC STENT. A 14-6/5.8/75 XXL VASCULAR WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 5 ATMOSPHERES FOR 1 SECOND, THE BALLOON BURST. THE DEVICE WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21850221 ↗
• MalfunctionApr 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS ILIAC ARTERY. A 14-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 2 ATMOSPHERES. THE DEVICE WAS REMOVED IMMEDIATELY WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21830105 ↗
• MalfunctionDec 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH LEFT ILIAC VEIN COMPRESSION AND UNDERWENT STENTING. AFTER FLUSHING, PRE-DILATATION WAS PERFORMED USING A 10X12 MUSTANG BALLOON CATHETER FOLLOWED BY A 14-6/5.8/75 XXL VASCULAR BALLOON CATHETER. DURING INFLATION OF THE XXL BALLOON AT 5 ATMOSPHERES, IT WAS NOTED THAT THE LIQUID IN THE PRESSURE PUMP CHANGED FROM TRANSPARENT TO RED, THE PRESSURE WOULD NOT RISE, AND THE LIQUID IN THE PRESSURE PUMP DECREASED. AFTER REMOVAL, A HOLE WAS NOTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904185 ↗
• MalfunctionSep 26, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT THE BALLOON BECAME STUCK IN THE INTRODUCER, AND THE BALLOON BROKE. A 14 MM X 6 CM, 75 CM XXL VASCULAR BALLOON WAS SELECTED FOR AN ARTERIOVENOUS FISTULA (AVF) DILATATION PROCEDURE. WHEN ATTEMPTING TO ADVANCE THE BALLOON THROUGH AN 8 FRENCH NON-BOSTON SCIENTIFIC INTRODUCER, THE BALLOON BECAME STUCK. THE BALLOON THEN BROKE INSIDE THE INTRODUCER WHEN IT WAS ATTEMPTED TO WITHDRAW IT. IT TOOK APPROXIMATELY TEN MINUTES TO RETRIEVE THE BALLOON AND THEN REPLACE THE INTRODUCER AND BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER XXL BALLOON, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310721 ↗
• MalfunctionSep 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT COMMON ILIAC. A 14-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279583 ↗
• MalfunctionAug 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 14-2/5.8/75 XXL WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS INSERTED. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19959728 ↗
• MalfunctionJul 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 71% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 12-4/5.8/75 XXL VASCULAR BALLOON WAS ADVANCED FOR DILATION. HOWEVER, WHEN PRESSURIZED AT 8 ATMOSPHERES, THE BALLOON RUPTURED ON A STENT STRUT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19674900 ↗

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