XXL™ Vascular M001145120Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729162926), received between Jun 10, 2020 and Aug 12, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 14-2/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INFLATION, THE BALLOON RUPTURED INSIDE THE ARTERY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379164 ↗
• MalfunctionMay 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH MAY-THURNER SYNDROME. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED COMMON ILIAC VEIN AND EXTERNAL ILIAC VEIN. A 14-2/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR POST DILATATION OF A WALLSTENT AND A NON-BOSTON SCIENTIFIC (BSC) STENT. THE FIRST INFLATION IN THE COMMON ILIAC VEIN WAS FINE. HOWEVER, DURING THE SECOND INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT AND A TEAR WAS NOTICED AT THE MID PART OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14324564 ↗
• MalfunctionAug 21, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED PULMONARY ARTERY. A 14-2/5.8/75 XXL BALLOON CATHETER WAS USED FOR DILATATION. HOWEVER, DIFFICULTIES WERE ENCOUNTERED DURING REMOVAL AND THE BALLOON COULD NOT BE REMOVED. SUBSEQUENTLY, THE SHEATH AND BALLOON WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10438756 ↗
• MalfunctionAug 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN AN AREA OF IN-STENT RESTENOSIS OF A VICI STENT IN A MODERATELY TORTUOUS RIGHT ILIAC VEIN. A 14-2/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10437027 ↗
• MalfunctionJun 10, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT ILIAC VEIN. A 14-2/5.8/75 XXL VASCULAR BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10140393 ↗