Atlas® AT75184Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741062490), received between May 16, 2017 and Jun 3, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Deflation Problem; Inflation Problem; Difficult to Remove; Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER WAS ALLEGEDLY UNABLE TO INFLATE AND DEFLATE. IT WAS FURTHER REPORTED THAT THERE IS A DIFFICULTY IN RETRACTING THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25371581 ↗
• MalfunctionMay 20, 2024Material Frayed; Inflation Problem; Unraveled Material; Material Deformation; Material Frayed; Inflation Problem; Unraveled Material; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN POPLITEAL VEIN VIA ILIAC VEIN STENOSIS, THE PTA BALLOON WAS ALLEGEDLY FAILED TO INFLATE SITU UPON INSPECTION. IT WAS FURTHER REPORTED THAT THE MIDSECTION OF THE BALLOON WAS FOUND TO BE CONSTRAINED. THE BALLOON WORKED SUCCESSFULLY FOR THE FIRST 2 INFLATIONS AND THE PATIENT RECEIVED ADEQUATE THERAPY. REPORTEDLY, SOME DISLODGED FIBERS WERE REPORTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19349908 ↗
• MalfunctionMar 15, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON UNABLE TO DEFLATE AND CANNOT BE REMOVED FROM THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11479186 ↗
• MalfunctionJul 16, 2020Unraveled Material; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AT75184 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED UNRAVELED MATERIAL. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10281444 ↗
• MalfunctionJul 24, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7716970 ↗
• MalfunctionJul 24, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7716903 ↗
• MalfunctionNov 28, 2017Material Frayed; Peeled/Delaminated; Material Rupture; Material Frayed; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE BEHIND THE KNEE, THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE DURING THE FIRST INFLATION ATTEMPT. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7063875 ↗
• MalfunctionNov 20, 2017Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE BACK OF THE KNEE, THE PTA BALLOON ALLEGEDLY RUPTURED ON THE FIRST INFLATION ATTEMPT AT NOMINAL PRESSURE. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7045556 ↗
• MalfunctionOct 31, 2017Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING THE FIRST INFLATION, THE BALLOON CATHETER WAS INFLATED TO 1-2 ATM PAST NOMINAL PRESSURE, POST DILATING A STENT IN THE ILIAC, WHEN THE BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED BY THE HEALTH CARE PROVIDER THAT THE BALLOON ALLEGEDLY HAD A PINHOLE RUPTURE. THERE WERE NO REPORTED RETRACTION DIFFICULTIES THROUGH THE STENT OR THE SHEATH. REPORTEDLY, THE BALLOON CATHETER WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6990880 ↗
• MalfunctionMay 16, 2017Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED THAT POST ANGIOPLASTY PROCEDURE, THE PTA BALLOON CATHETER ALLEGEDLY BROKE AT THE GLUE JOINT UPON REMOVAL THROUGH THE SHEATH. THE PROCEDURE WAS CONCLUDED, AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6571339 ↗