Atlas® Gold ATG120162Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741060809), received between Jul 6, 2017 and Dec 20, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2023Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT FEMORAL ARTERY, WHEN ATTEMPTING TO WITHDRAW THE BALLOON CATHETER THROUGH THE INTRODUCER, THE BALLOON ALLEGEDLY WOULD NOT RE-ENTER THE INTRODUCER AND SUBSEQUENTLY DETACHED FROM THE SHAFT AND ALLEGEDLY COULD NOT BE REMOVED. IT WAS FURTHER REPORTED THAT THE INTRODUCER AND BALLOON WERE ALLEGEDLY REMOVED THROUGH THE FEMORAL VESSEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18368659 ↗
• InjuryNov 16, 2020Deflation Problem; Retraction Problem; Detachment of Device or Device Component; Deflation Problem; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PTA PROCEDURE, THE DEVICE WAS ALLEGEDLY UNABLE TO DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS MANAGED TO DESTABILIZE AND WAS REMOVED OUT OF THE PATIENT. CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10842041 ↗
• MalfunctionOct 26, 2020Deflation Problem; Retraction Problem; Detachment of Device or Device Component; Deflation Problem; Retraction Problem; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG120162 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION PROBLEM, DETACHMENT AND RETRACTION ISSUE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE 90 YEAR OLD MALE PATIENT WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10736568 ↗
• MalfunctionApr 16, 2020Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL ATG120162 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED DEVICE DAMAGED PRIOR TO USE AND BREAK. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION DID NOT INVOLVE A PATIENT. PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9968566 ↗
• MalfunctionJul 6, 2017Peeled/Delaminated; Material Rupture; Unraveled Material; Peeled/Delaminated; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, AN ALLEGED HOLE WAS OBSERVED AT THE PROXIMAL END OF THE BALLOON. 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 6691402 ↗