Occlusion Balloon Catheter M001173010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729112495), received between Sep 9, 2019 and Apr 28, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT BALLOON POPPED DURING INFLATION. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED HEPATIC VEIN. AN OCCLUSION BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON POPPED DURING FIRST INFLATION AT 2 ATMOSPHERES FOR LESS THAN 10 SECONDS. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT ANY FRAGMENTS LEFT. ADDITIONALLY, MULTIPLE KINKS WERE NOTED WITH THE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUSION BALLOON. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916831 ↗
• MalfunctionAug 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN INTERNAL ILIAC ARTERY/HYPOGASTRIC ARTERY. AN OB/6-6/2/80 OCCLUSION BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON THREADED INTO THE GUIDEWIRE AND UPON INFLATION, THE OCCLUSION BALLOON BURST, AND THE CONTRAST CAME TO THE ARTERY CIRCULATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20013744 ↗
• MalfunctionMay 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE VISCERAL AREA. AN OCCLUSION BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS ADVANCED THROUGH AN 8F SHEATH TO OCCLUDE THE VESSEL. HOWEVER, IT BURST UPON FIRST INFLATION AT 10ATM WITHIN 30 SECONDS. THE DEVICE WAS REMOVED ALONG WITH THE WIRE ASSEMBLY AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14442587 ↗
• MalfunctionDec 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THE BALLOON RUPTURED. AN OCCLUSION BALLOON WAS SELECTED FOR USE IN A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE IN THE LIVER VEIN. THE ANATOMY WAS NOT TORTUOUS, NOT CALCIFIED, AND HAD NO STENOSIS. DURING THE PROCEDURE, THE BALLOON RUPTURED WHILE BEING INFLATED, IN THE LIVER VEIN. THE BALLOON WAS SIMPLY RETRACTED WITH THE GUIDEWIRE IN PLACE, AND WAS REPLACED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12917527 ↗
• MalfunctionSep 9, 2019Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WOULD NOT STAY INFLATED. A 6-6/2/80 OCCLUSION BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WENT INSIDE THE PATIENT'S BODY. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON BUT IT WOULD NOT MAINTAIN THE INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8975349 ↗