Atlas® Gold ATG120144Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801741060762), received between Apr 13, 2018 and Sep 24, 2025 — classified as 4 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (19 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  ON (B)(6) 2025, A PATIENT WAS UNDERGOING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS GOLD BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER WAS NOT DEFLATING FULLY AND ALLEGEDLY STUCK INSIDE THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23130512 ↗
• MalfunctionApr 2, 2025Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 15 ATM. IT WAS FURTHER REPORTED THAT THERE WAS MILD DIFFICULTY IN REMOVING THE BALLOON FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750601 ↗
• MalfunctionJul 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE RADIOPAQUE MARKERS WERE ALLEGEDLY NOT LOCATED AT THE ENDS OF 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 19836325 ↗
• MalfunctionJan 24, 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 ALLEGEDLY HAD A LACK OF PRESSURE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY CAME LOOSE FROM THE AXIAL CATHETER TO WHICH IT SHOULD HAVE BEEN ATTACHED. IT WAS ALLEGEDLY DETACHED COMPLETELY ONCE IT CAME OUT OF THE INTRODUCER FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569245 ↗
• MalfunctionJan 17, 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 ALLEGEDLY GOT RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18524295 ↗
• MalfunctionJan 16, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CEPHALIC VEIN ARCH, THE PTA BALLOON WAS ALLEGEDLY DETACHED FROM THE BALLOON CATHETER. IT WAS FURTHER REPORTED THAT THE BALLOON WAS TRIED TO BE CAPTURED WITH A CATCHER TO NO AVAIL, AND BIOPSY FORCEPS WERE USED TO REMOVE THE DETACHED BALLOON SAC BODY OUT OF THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18515650 ↗
• MalfunctionDec 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN ABDOMINAL AORTIC THROUGH FEMORAL ARTERY APPROACH, THE PTA BALLOON WAS ALLEGEDLY FOUND TO BE LEAKING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18316955 ↗
• MalfunctionDec 7, 2023Inflation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Inflation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD AN INFLATION ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18280654 ↗
• MalfunctionNov 30, 2023Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN RIGHT ANTERIOR VENOUS, THE BALLOON ALLEGEDLY HAD DETACHED FROM THE CATHETER AND REMAINED PARTIALLY INFLATED AT THE INTERIOR OF THE VENA CAVA. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY STUCK IN THE PARTIALLY SWOLLEN TREATMENT SITE. REPORTEDLY, THE BALLOON HAD TO BE DEFLATED WITH SERRATED BIOPSY FORCEPS BY TEARING THE BALLOON AND THE BALLOON WAS RETRIEVED VIA A LOOP CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241106 ↗
• MalfunctionAug 24, 2023Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ANGIOPLASTY PROCEDURE IN THE CENTRAL VEIN, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT AFTER THE DILATION, THE BALLOON ALLEGEDLY DETACHED FROM THE CATHETER. IT WAS ALSO REPORTED THAT THE PTA BALLOON CATHETER WAS REMOVED USING SNARE AND WITHDRAWN THE PUNCTURED BALLOON INTO THE SHEATH AND COMPLETED THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17620612 ↗
• MalfunctionMay 22, 2023Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR AN ABDOMINAL AORTIC ANEURYSM GRAFT VIA FEMORAL ACCESS, THE PTA BALLOON ALLEGEDLY RUPTURED AFTER POST DILATION OF STENT. IT WAS FURTHER REPORTED THAT UPON REMOVAL OF THE BALLOON THE INTERNAL SHAFT WIRE SEPARATED. THE BALLOON WAS REMOVED SUCCESSFULLY BY USING SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974089 ↗
• MalfunctionApr 26, 2023Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN A HIGHLY CALCIFIED LESION, THE PTA BALLOON ALLEGEDLY RUPTURED AT THE TIME OF DILATION. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY GOT DETACHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16813806 ↗
• MalfunctionApr 11, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE PULMONARY ARTERY, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16713057 ↗
• MalfunctionMay 31, 2022Leak/Splash; Material Rupture; Material Split, Cut or Torn; Leak/Splash; Material Rupture; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC VEIN, THE PTA BALLOON ALLEGEDLY FAILED TO OPEN IN THE ILIAC VEIN UPON ATTEMPTING TO INFLATE. IT WAS FURTHER REPORTED THAT PHYSICIAN REMOVED THE BALLOON FROM PATIENT'S BODY AND IDENTIFIED LEAKAGE OF THE BALLOON AT THE PROXIMAL END. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14546145 ↗
• MalfunctionFeb 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED BEFORE INFLATION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13617166 ↗
• MalfunctionJan 24, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE SUBCLAVIAN VEIN TO TREAT CENTRAL VENOUS PLASTY, THE PTA BALLOON ALLEGEDLY UNABLE TO BE REMOVED OUT OF THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13330992 ↗
• MalfunctionJan 4, 2022Deflation Problem; Air/Gas in Device; Deflation Problem; Air/Gas in Device

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA LEFT POPLITEAL VEIN, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO ASPIRATE. DESPITE REPEATED ASPIRATIONS, THE PTA BALLOON WAS UNABLE TO DEFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152947 ↗
• InjuryDec 29, 2021Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT BRACHIOCEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 7 ATM AND DETACHED FROM THE CATHETER WITHIN THE SUBCLAVIAN VEIN. IT WAS FURTHER REPORTED THAT PHYSICIAN ATTEMPTED TO LOOP AND REMOVE THE BALLOON BY ACCESSING THE BRACHIAL VEIN USING FOREIGN BODY RESCUE HANDLE; HOWEVER, THE BALLOON WAS UNABLE TO BE REMOVED. REPORTEDLY, THE PTA BALLOON WAS REMOVED USING UROLOGY FORCEPS THROUGH THE INTRODUCER SHEATH BY PUNCTURING THE SITE IN THE RIGHT BASILICA VEIN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. PATIENT REPORTED AS STABLE.

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

  MAUDE report 13109175 ↗
• MalfunctionSep 30, 2021Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12552061 ↗
• MalfunctionMay 12, 2021Material 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 AT 6 ATM. IT WAS FURTHER REPORTED THAT AFTER RETRACTION OF THE CATHETER, A PIECE OF THE BALLOON WAS PRESENT INSIDE THE STENT AND SUCCESSFULLY REMOVED THROUGH A SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11811346 ↗
• MalfunctionMar 15, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY DISLOCATED FROM ITS ORIGINAL POSITION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11480495 ↗
• InjuryJan 18, 2021Deflation Problem; Material Rupture; Unraveled Material; Detachment of Device or Device Component; Material Deformation; Deflation Problem; Material Rupture; Unraveled Material; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BALLOON WAS ALLEGEDLY UNABLE TO DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED AND THE SHAFT WAS REMOVED. THE PATIENT HAD TO UNDERGO STENTING TO MAKE SURE THE BALLOON PIECES DID NOT TRAVEL THROUGHOUT THE BODY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 11184259 ↗
• MalfunctionJan 4, 2021Break; Material Rupture; Break; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11106565 ↗
• MalfunctionOct 26, 2020Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG120144 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, WEIGHT AND GENDER OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10736535 ↗
• MalfunctionApr 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG120144 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS A MALE; WEIGHT AND AGE WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968560 ↗