Atlas® Gold ATG120204Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741060946), received between Apr 15, 2019 and Dec 18, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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.

• MalfunctionDec 18, 2023Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED DURING DILATATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18342540 ↗
• MalfunctionOct 10, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY NOT PUMPING PROPERLY. IT WAS FURTHER REPORTED THAT HARD TIME TO DEFLATE THE BALLOON IN POST PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15568736 ↗
• MalfunctionOct 10, 2022Deflation Problem; Inflation Problem; Difficult to Remove; Deflation Problem; Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD DIFFICULTLY TO PULL OUT OF THE CATHETER. IT WAS FURTHER REPORTED THAT THE BALLOON HAD A HARD TIME TO INFLATE AND DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15568730 ↗
• MalfunctionJul 26, 2022Deflation Problem; Inflation Problem; Material Deformation; Deflation Problem; Inflation Problem; Material Deformation

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD ABNORMAL INFLATION. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY HAD DEFLATION PROBLEM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15101363 ↗
• MalfunctionNov 10, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10815683 ↗
• MalfunctionJan 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL ATG120204 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVE A PATIENT WITH NO REPORTED CONSEQUENCES. THE (B)(6) YEAR OLD MALE PATIENT'S WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593193 ↗
• MalfunctionApr 15, 2019Deflation Problem; Material Rupture; Deflation Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL ATG120204 PTA BALLOON DILATATION CATHETER EXPERIENCED A DEFLATION ISSUE AND MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS A 21 YEAR OLD MALE, WEIGHING 150 POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515270 ↗