XXL™ Esophageal M001145530Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729163084), received between Oct 30, 2018 and Apr 15, 2026 — classified as 1 death, 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.

• MalfunctionApr 15, 2026Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. AN XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION AT 2 ATMOSPHERES, THE BALLOON LEAK AND WOULD NOT GO ABOVE 2 ATMOSPHERES AND DID NOT REACH THE REQUIRED PRESSURE. IT WAS DETERMINED THAT THE BALLOON RUPTURED. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885649 ↗
• MalfunctionMay 31, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED COMMON ILIAC VEIN. A 16-4/5.8/120 XXL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTICED THAT THE PRESSURE IN THE ENCORE INFLATION DEVICE WAS NOT INCREASING. UPON REMOVAL OF THE PRODUCT TO INSPECT AND WHEN THE PHYSICIAN TRIED TO INFLATE THE BALLOON OUTSIDE THE PATIENT'S BODY, A FEW VISIBLE PINHOLES WERE NOTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14550122 ↗
• DeathDec 22, 2021Break; Break

  IT WAS REPORTED THAT THE BALLOON BROKE OFF INSIDE THE PATIENT, AND THE PATIENT IS NOW DECEASED. A 16MM X 4CM X 120CM XXL ESOPHAGEAL BALLOON DILATATION CATHETER WAS SELECTED FOR USE IN A PROCEDURE. THE BALLOON BROKE OFF IN THE PATIENT. THE BALLOON BECAME STUCK IN THE SHEATH AND WAS ABLE TO BE PULLED OUT OF THE PATIENT. IT WAS REPORTED THE PATIENT IS NOW DECEASED, BUT REPORTED TO NOT BE RELATED TO THE BROKEN XXL BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13065001 ↗
• MalfunctionJul 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE AORTIC ARCH. A 16-4/5.8/120 XXL ESOPHAGEAL BALLOON WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOT INTACT AND NOTED TO BE RUPTURED DURING THE CASE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS GOOD. IT WAS FURTHER REPORTED THAT THE MORE THAN 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDY CALCIFIED AORTIC ARCH. THE BALLOON RUPTURED ON THE THIRD INFLATION AT 5 ATMOSPHERES FOR 10 TO 15 SECONDS. THE DEVICE WAS SMOOTHLY REMOVED FROM THE PATIENT'S BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10280548 ↗
• MalfunctionMay 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT ILIAC VEIN. A 16-4/5.8/120 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON INITIAL INFLATION AT 5 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10025505 ↗
• 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 <=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 PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8020332 ↗