Atlas® Gold ATG120184Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741060885), received between Dec 13, 2017 and Dec 11, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2025Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS GOLD PTA BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT SURGICAL INTERVENTION (GASTROSCOPY) TO REMOVE THE BALLOON FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 23775742 ↗
• MalfunctionJul 10, 2024Material 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 WAS ALLEGEDLY RUPTURED AT 20 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY COMPLETELY DETACHED INSIDE THE PATIENT'S LEFT ILIAC VEIN. REPORTEDLY, THE DETACHED COMPONENT WAS REMOVED FROM THE PATIENT BY THROMBECTOMY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710729 ↗
• MalfunctionNov 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, UPON REMOVAL OF THE BALLOON FROM THE PATIENT, IT WAS NOTED THAT THE BALLOON MATERIAL WAS ALLEGEDLY NOT PRESENT OF THE DELIVERY CATHETER. IT WAS FURTHER REPORTED THAT THE NO BALLOON MATERIAL WAS FOUND INSIDE THE PATIENT UNDER FLUOROSCOPY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18054675 ↗
• MalfunctionNov 17, 2022Deflation Problem; Inflation Problem; Difficult to Remove; Material Rupture; Material Twisted/Bent; Deflation Problem; Inflation Problem; Difficult to Remove; Material Rupture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN LEFT FEMORAL VEIN, THE PTA BALLOON ALLEGEDLY FAILED TO INFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY FAILED TO DEFLATE AND BENT. REPORTEDLY, THE BALLOON ALLEGEDLY RUPTURED AND DIFFICULT TO REMOVE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15821917 ↗
• MalfunctionAug 10, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD LABELLING ISSUE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15196728 ↗
• MalfunctionApr 27, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE EXPIRATION DATE PRINTED IN PRODUCT'S LABEL WAS ALLEGEDLY NOT THE SAME FROM COMMERCIAL INVOICE, PACKING LIST AND STERILITY CERTIFICATE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14217652 ↗
• MalfunctionMar 28, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR THE TREATMENT OF PLACENTA PREVIA VIA FEMORAL ARTERY, THE PTA BALLOON WAS DIFFICULT TO REMOVE FROM THE VASCULAR SHEATH AND IT WAS FOUND TO BE DEGUMMED. IT WAS FURTHER REPORTED THAT BALLOON AND SHEATH WERE REMOVED TOGETHER AS A UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13926574 ↗
• MalfunctionMar 28, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR THE TREATMENT OF PLACENTA PREVIA VIA FEMORAL ARTERY, THE PTA BALLOON WAS DIFFICULT TO REMOVE FROM THE VASCULAR SHEATH AND IT WAS FOUND TO BE DEGUMMED. IT WAS FURTHER REPORTED THAT BALLOON AND SHEATH WERE REMOVED TOGETHER AS A UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13926467 ↗
• InjuryJul 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY DISCONNECTED FROM THE SYSTEM. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WAS ABLE TO PERFORATE THE IMPACTED BALLOON WITH A US-GUIDED NEEDLE AND RETRIEVE THE FOLDED BALLOON IN THE COMMON FEMORAL VEIN VIA OPEN DISSECTION. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12120836 ↗
• MalfunctionApr 19, 2021Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG120184 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED LEAK AND MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686030 ↗
• InjuryFeb 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERIOR VENA CAVA, THE PTA BALLOON WAS ALLEGEDLY FOUND TO BE DETACHED. A SNARE WAS USED TO RETRIEVE THE DETACHED MATERIAL, VIA AN ALTERNATE ACCESS SITE. NO FURTHER TREATMENT WAS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 8337526 ↗
• MalfunctionJan 7, 2019Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY HAD DIFFICULTY RETRACTING AND GOT STUCK INSIDE THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8224141 ↗
• MalfunctionDec 13, 2017Break; Retraction Problem; Unraveled Material; Break; Retraction Problem; Unraveled Material

  IT WAS REPORTED THAT DURING AN UPPER ARM FISTULA THE PTA BALLOON MATERIAL ALLEGEDLY BEGAN TO UNRAVEL AT THE DISTAL END OF THE BALLOON WHEN THE INFLATION ATTEMPT WAS AT APPROXIMATELY 6ATM. 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 7113294 ↗
• MalfunctionDec 13, 2017Retraction Problem; Unraveled Material; Detachment of Device or Device Component; Retraction Problem; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UPPER ARM FISTULA THE PTA BALLOON MATERIAL ALLEGEDLY BEGAN TO UNRAVEL AT THE DISTAL END OF THE BALLOON WHEN THE INFLATION ATTEMPT WAS AT APPROXIMATELY 6ATM. 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 7113099 ↗