XXL™ Vascular M001145150Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729190479), received between Sep 24, 2018 and Apr 13, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT VENOUS THROMBECTOMY. THE 25% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED BILATERAL ILIAC, FEMORAL VEINS AND INFERIOR VENA CAVA (IVC). AN ANGIOPLASTY WAS THEN PERFORMED TO PRE-DILATE THE CHRONIC CLOT AND PLACED VENOUS WALLSTENTS. A 14-4/5.8/120 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. BALLOON INFLATED TWO TIMES, HOWEVER; DURING SECOND INFLATION AT 4 TO 5 ATMOSPHERES, IT DID NOT REACH THE DESIRED PROFILE AND THE BALLOON BURST. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16739149 ↗
• MalfunctionJun 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 14-4/5.8/120 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST 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 14841223 ↗
• MalfunctionJan 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THE BALLOON WAS DAMAGED BY THE STENT. A XXL VASCULAR BALLOON AND WALLSTENT WERE SELECTED FOR USE. THE WALLSTENT WAS SUCCESSFULLY IMPLANTED AND THE XXL VASCULAR BALLOON WAS CHOSEN FOR POST-DILATION. AS THE BALLOON CROSSED THE IMPLANTED STENT, IT BECAME DAMAGED BY THE STENT. THE BALLOON WAS UNABLE TO INFLATE, AND BLOOD WAS RETURNING IN THE BALLOON CATHETER. ANOTHER XXL BALLOON WAS USED FOR POST-DILATION. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282679 ↗
• MalfunctionFeb 19, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE AORTA. A 14-4/5.8/120MM XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9728551 ↗
• MalfunctionJan 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INFRARENAL ILIAC VESSEL. A 14-4/5.8/120 XXL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 4 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS ALL RIGHT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9556007 ↗
• MalfunctionOct 30, 2018Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT SIDE. THE 60% STENOSED, 60MM IN LENGTH, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED, AND 14MM IN DIAMETER ILIAC VESSEL. THE LESION CONTAINED LESS THAN 45 DEGREES BEND. A 14-4/5.8/120 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON WAS BROKEN. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE SHAFT WAS NOT BROKEN BUT THE BALLOON RUPTURED. ON INITIAL INFLATION THE BALLOON WENT DOWN AND COULD NOT BE INFLATED ANYMORE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. A 16-4/5.8/120 XXL ESOPHAGEAL BALLOON CATHETER WAS ALSO ADVANCED FOR DILATION BUT ALSO RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND ANOTHER BALLOON COMPLETED THE PROCEDURE. THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8019603 ↗
• InjuryOct 10, 2018Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESIONS WERE LOCATED IN THE INFERIOR VENA CAVA (IVC) AND ILIAC VEINS. FOLLOWING STENTING, POSTDILITATION WAS PERFORMED WITH A 14-4/5.8/120 XXL VASCULAR BALLOON CATHETER. DURING WITHDRAWAL, THE BALLOON WAS BLOCKED AT THE ENTRY OF THE 9F INTRODUCER SHEATH. IT WAS NOTED THAT THE BALLOON HAD RUPTURED AND WAS SEPARATED FROM THE CATHETER DISTAL MARKER. THE BALLOON REMAINS BLOCKED THE RIGHT INTERNAL JUGULAR VEIN. AN OPEN APPROACH WAS NOT EFFECTIVE IN RETRIEVING THE BALLOON MATERIAL SAFELY FROM THE PUNCTURE SITE; AN ENDOVASCULAR SNARING FROM THE BRACHIAL VEIN ACCESS WAS ATTEMPTED BUT IT CAUSED MIGRATION OF THE BALLOON MATERIAL INTO THE BRANCHES OF THE PULMONARY ARTERY. THE BALLOON REMAINS WERE RETRIEVED BY ENDOVASCULAR MEANS FROM THE PULMONARY ARTERY TO THE BRACHIAL VEIN AND THE RIGHT BRACHIAL VEIN WAS EXCISED BY PHLEBOTOMY TO COMPLETE THE PROCEDURE. THE PATIENT WAS HOSPITALIZED THREE DAYS FOR OBSERVATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. THE DEVICE WAS RETURNED FOR ANALYSIS. THE XXL DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED. THE DEVI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7953641 ↗
• MalfunctionSep 24, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 14-4/5.8/120MM XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER XXL BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7902523 ↗