Atlas® Gold ATG120126Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741060724), received between Nov 26, 2020 and Nov 4, 2025 — classified as 6 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.

• MalfunctionNov 4, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS GOLD PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED. FURTHER, IT WAS UPDATED THAT THEY WERE ABLE TO FIND THE HOLE IN THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460633 ↗
• MalfunctionDec 11, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA LEFT LATERAL APPROACH, THE PTA BALLOON ALLEGEDLY COULD NOT BE FULLY FILLED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20900281 ↗
• MalfunctionJul 10, 2024Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY CANNOT BE FILLED PROPERLY AFTER BEING SENT TO THE LESION LOCATION. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGEDLY A AIR LEAKAGE AT THE POSITION WHERE THE BALLOON HEAD OVERLAPPED WITH THE DELIVERY ROD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707899 ↗
• MalfunctionFeb 2, 2024Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE TO TREAT THE ILIAC VEIN STENOSIS, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18629969 ↗
• MalfunctionApr 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN A CALCIFIED LESION, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT BLOOD WAS ALLEGEDLY FOUND IN THE SHAFT AFTER DEFLATING THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16805244 ↗
• MalfunctionNov 26, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE BALLOON ALLEGEDLY RUPTURED AND FAILED TO INFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10910951 ↗