Atlas® Gold ATG120142Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741060748), received between Jun 20, 2018 and Sep 29, 2022 — 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.

• MalfunctionSep 29, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY DETACHED FROM ITS SHAFT. REPORTEDLY, THE BALLOON WAS REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15507204 ↗
• MalfunctionDec 29, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE CATHETER OF THE DEVICE HAS ALLEGEDLY BROKE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11085791 ↗
• MalfunctionJan 15, 2020Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG120164 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK, LEAK, INFLATION ISSUE, AND MATERIAL PUNCTURE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT WAS REPORTED AS A (B)(6) YEAR-OLD FEMALE WEIGHING (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9592088 ↗
• MalfunctionAug 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE MARKER BANDS OF THE PTA BALLOON WERE ALLEGEDLY DISLOCATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7835666 ↗
• InjuryJun 20, 2018Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC VEIN, THE PTA BALLOON ALLEGEDLY GOT STUCK INSIDE A WALL STENT AND SUBSEQUENTLY RUPTURED CIRCUMFERENTIALLY DURING THE FIRST INFLATION (ATM UNKNOWN). IT WAS FURTHER REPORTED THAT UPON RETRACTION THROUGH THE 8FR SHEATH, THE BALLOON MATERIAL DETACHED AND TURNED INSIDE OUT. REPORTEDLY, THE HEATH CARE PROVIDER (HCP) ATTEMPTED TO REMOVE THE BALLOON THROUGH THE 8FR SHEATH BUT WAS UNSUCCESSFUL. THE HCP DECIDED TO CUT THE BALLOON AND THE CATHETER WIRE AND PLACE A 14FR SHEATH BUT STILL WAS NOT ABLE TO REMOVE THE DETACHED BALLOON SEGMENT. THE HCP UPSIZED THE SHEATH TO 18FR AND WAS ABLE TO REMOVE THE DETACHED BALLOON SEGMENT SUCCESSFULLY. 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 7622642 ↗