Equalizer™ M001171120Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729402428), received between Sep 4, 2018 and Dec 13, 2020 — classified as 6 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED STENT GRAFT IN A VESSEL. A 40/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON INITIAL INFLATION AT 12 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10998988 ↗
• MalfunctionFeb 19, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATE IN THE AORTA. A 40X7X2X100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 8 ATMOSPHERES FOR 8 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9728954 ↗
• MalfunctionMay 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE AORTA. A 40/7/2/100CM EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637344 ↗
• MalfunctionSep 27, 2018Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE AND BECAME STUCK IN THE ENDOPROSTHESIS. TWO 40X100 EQUALIZER BALLOONS WERE SELECTED FOR A PROCEDURE IN THE AORTIC ENDOPROSTHESIS. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE BALLOONS WERE NOT FOLDED UPON THEMSELVES. RATHER, THEY SEEMED OPENED AND INFLATED. WHEN REMOVING THE BALLOONS, THEY BECAME STUCK WITHIN THE UPPER HOOKS OF THE ENDOPROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7915715 ↗
• MalfunctionSep 27, 2018Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE AND BECAME STUCK IN THE ENDOPROSTHESIS. TWO 40X100 EQUALIZER BALLOONS WERE SELECTED FOR A PROCEDURE IN THE AORTIC ENDOPROSTHESIS. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE BALLOONS WERE NOT FOLDED UPON THEMSELVES. RATHER, THEY SEEMED OPENED AND INFLATED. WHEN REMOVING THE BALLOONS, THEY BECAME STUCK WITHIN THE UPPER HOOKS OF THE ENDOPROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7915534 ↗
• MalfunctionSep 4, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A 40/7/2/100 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON INITIAL INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7844100 ↗