XXL™ Esophageal M001145580Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729163176), received between Aug 28, 2018 and Mar 6, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 40% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. AN 18-4/5.8/120 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON WAS RUPTURED INSIDE THE PATIENT. THE BALLOON DID NOT REACH THE NOMINAL PRESSURE OF 5 ATMOSPHERES AS IT RUPTURED AT 2 ATMOSPHERES AND THERE WAS BLOOD IN THE INSUFFLATOR HOSE. THE DEVICE WAS SIMPLY REMOVED IN ONE PIECE, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537939 ↗
• MalfunctionMar 29, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND LEAK OCCURRED. ON (B)(6) 2020, A BALLOON DILATION ON THE ESOPHAGUS USING AN 18-4/5.8/120 XXL BALLOON DILATOR WAS PREPARED FOR THE PROCEDURE. DURING PREPARATION, A LEAK TEST ON THE CATHETER NOTED THAT THE BALLOON WAS LEAKING AIR. HOWEVER, A VIDEO WAS PROVIDED THAT SHOWED THAT A PINHOLE WAS FOUND ON THE BALLOON, WHICH CONTRIBUTED TO THE LEAK WHERE LIQUID WAS COMING OFF. THE DEVICE WAS REMOVED AND REPLACED FOR A DIFFERENT MODEL TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19007533 ↗
• MalfunctionOct 30, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION SLOW OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ILIAC VEIN. AN 18-4/5.8/120 XXL BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED USING AN ENCORE INFLATION DEVICE WITH A RATIO OF 50 TO 50. HOWEVER, DURING THE PROCEDURE, THE DEFLATION TIME WAS TOO SLOW. THE DEVICE WAS REMOVED FROM THE PATIENT IN A DEFLATED STATE, AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS OR INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18034722 ↗
• MalfunctionFeb 3, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION SLOW OCCURRED. THE TARGET LESION WAS LOCATED IN ESOPHAGEAL ARTERY. A 18-4/5.8/120 XXL ESOPHAGEAL BALLOON DILATOR WAS ADVANCED FOR DILATATION. HOWEVER, DURING DEFLATION, THE DEFLATION TIME TOOK ABOUT MORE THAN 50 SECONDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT IS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292535 ↗
• MalfunctionJun 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE PULMONARY ARTERY. A 18-4/5.8/120 XXL ESOPHAGEAL BALLOON DILATOR WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED AT WHICH THE NORMAL PRESSURE OF THE DEVICE DID NOT REACH 5 ATMOSPHERES. HOWEVER, THE BALLOON EXPLODED AND NO MORE PRESSURE WAS APPLIED TO THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14757980 ↗
• MalfunctionJan 31, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. AFTER FLUSHING, A 18-4/5.8/120 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, UPON INFLATION, IT WAS NOTICED THAT THERE WAS LEAKAGE OF CONTRAST MEDIA FROM THE BALLOON. THE DEVICE WAS REMOVED AND UPON INFLATION OUTSIDE THE PATIENT, IT WAS NOTED THAT THE WAS A TINY HOLE ON THE SIDE OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9654520 ↗
• MalfunctionAug 28, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND CHRONIC THRUMBOS CALCIFIED RIGHT SUBCLAVIAN VEIN AND BRAQUEOCEFALIC TRUNK. AFTER DEPLOYMENT OF A WALLSTENT, A 18-4/5.8/120MM XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. DURING INFLATION AT 5 ATMOSPHERES FOR 1 MINUTE, THE PRESSURE DESCENDED TO 0 ATMOSPHERES AND IT WAS NOTED THAT BLOOD WAS PRESENT IN THE INFLATION DEVICE. THE DEVICE WAS COMPLETELY REMOVED BY SIMPLY MOVING BACK FROM THE PATIENT'S BODY AND IT WAS CONFIRMED THAT THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7824319 ↗