XXL™ Vascular M001145100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729096146), received between Sep 10, 2020 and Jul 4, 2024 — classified as 1 injury, 5 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.

• 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 ↗
• MalfunctionMay 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION IN AN ARTERIOVENOUS FISTULA OF RADIAL VESSEL. DURING INFLATION, THE BALLOON BURST INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286931 ↗
• MalfunctionAug 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INTRODUCTION, THE BALLOON RUPTURED IN STENT ILIAC VEIN LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484925 ↗
• MalfunctionAug 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442822 ↗
• MalfunctionJul 22, 2022Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15-JUL-2022. IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERIAL DISEASE. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 12-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, A KINK WAS NOTED ON THE BALLOON ITSELF. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15081418 ↗
• InjurySep 10, 2020Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CEPHALIC ARCH. A 12-4/5.8/75 XXL VASCULAR BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED, DEFLATED, AND WAS PULLED DOWN TO THE MID FISTULA. HOWEVER, UPON TRYING TO INFLATE THE BALLOON AGAIN, THE PRESSURE WOULD NOT INCREASE AND UPON PULLING BACK THE SYRINGE, BLOOD WAS NOTICED WHICH INDICATED THAT THE BALLOON HAD RUPTURED. THE DEVICE WAS PULLED OUT FROM THE SHEATH AND ENTIRE DEVICE ASIDE FROM THE TIP WAS NOT VISIBLE. THE TIP LODGED IN AN ANEURYSM THAT WAS SUCCESSFULLY RETRIEVED BY MAKING AN INCISION AND PULLING IT OUT USING A CURVED FORCEPS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 10514892 ↗