Atlas® Gold ATG80164Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00801741060816), received between Oct 6, 2016 and Sep 11, 2025 — classified as 12 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (33 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE USING THE ATLAS GOLD PTA BALLOON, THE BALLOON ALLEGEDLY BUSTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23024141 ↗
• MalfunctionMay 5, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS GOLD PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY CAUGHT IN THE SHEATH DURING EXTRACTION. IT WAS FURTHER REPORTED THAT THE BALLOON PART FELL OUT OF THE CATE WHEN IT WAS PULLED AND IT GOT CAUGHT ON THE SHEATH AND THE BALLOON PART BROKE OFF. REPORTEDLY, THE ENTIRE SHEATH WAS PULLED OUT AND THE BALLOON WAS SUCCESSFULLY REMOVED WITHOUT REMAINING IN THE BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959207 ↗
• MalfunctionApr 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE MARKERS ARE ALLEGEDLY NOT CORRECT IN LINE WITH THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880008 ↗
• InjuryAug 21, 2024Deflation Problem; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; 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 COULD NOT BE DEFLATED AFTER INFLATING TO 18 ATM AND THE PARTS OF THE DEVICE CAME OFF THE SHAFT. REPORTEDLY, MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE ITEM, BUT NOT ALL FRAGMENTS COULD BE RETRIEVED. ADDITIONALLY, THE PARTS OF THE DEVICE WHICH COULD BE RETRIEVED HAVE BEEN DISPOSED. THE CURRENT STATUS OF THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20016641 ↗
• MalfunctionMay 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 IN THE LEFT UPPER ARM FISTULA, THE PTA BALLOON ALLEGEDLY RUPTURED DURING FIRST INFLATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341821 ↗
• MalfunctionJan 31, 2024Break; 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, THE PTA BALLOON ALLEGEDLY CAME OFF THE SHAFT BUT WAS STILL ATTACHED TO THE INNER LUMEN. IT WAS FURTHER REPORTED THAT THE PTA BALLOON WAS PULLED INTO THE SHEATH AND REMOVED VERY SLOWLY TOGETHER WITH THE SHEATH AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18612645 ↗
• MalfunctionFeb 3, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY CAME FROM THE SHAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292810 ↗
• MalfunctionOct 21, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD LEAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649138 ↗
• MalfunctionSep 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED DURING FIRST INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15359838 ↗
• MalfunctionAug 3, 2022Break; Deflation Problem; Difficult to Remove; Break; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA UPPER ARM FISTULA FOR THE TREATMENT OF BRACHIOCEPHALIC STENOSIS, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE COMPLETELY. IT WAS FURTHER REPORTED THAT THE A NEEDLE WAS USED TO DEFLATE THE BALLOON. REPORTEDLY THE BALLOON AND THE SHEATH REMOVED TOGETHER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15155045 ↗
• MalfunctionAug 1, 2022Material Frayed; Unraveled Material; Detachment of Device or Device Component; Material Frayed; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA FEMORAL ACCESS OF A NON-CALCIFIED LESION, THE TIP OF THE BALLOON WAS ALLEGEDLY DETACHED BY A TISSUE FIBER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15137261 ↗
• MalfunctionMay 26, 2022Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT SUBCLAVIAN BRACHIOCEPHALIC VESSELS TO TREAT A CENTRAL VENOUS STENOSIS, THE BALLOON ALLEGEDLY BURST. IT WAS FURTHER REPORTED THAT THE BALLOON WAS NOT FOUND ON THE CATHETER WHILE REMOVING OUT OF THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14510789 ↗
• MalfunctionApr 19, 2022Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Packaging Problem; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT INNER PACKAGE WAS ALLEGEDLY DAMAGED WHICH LOST STERILITY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14139801 ↗
• InjuryMar 2, 2022Difficult 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 POPLITEAL VEIN, THE BALLOON WAS ALLEGEDLY RUPTURED AT 8 ATM AND THE PHYSICIAN WAS UNABLE TO REMOVE THE BALLOON. IT WAS FURTHER REPORTED THAT THE BALLOON SHAFT FRACTURED AND THE BALLOON CATHETER TIP WAS ALLEGEDLY LODGED IN THE POPLITEAL VEIN. REPORTEDLY, PHYSICIAN GAINED VARIOUS ACCESS THROUGH DIFFERENT AREAS TO REMOVE THE DETACHED BALLOON FROM THE BODY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 13647801 ↗
• MalfunctionFeb 10, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF THE INFERIOR VENA CAVA, THE BALLOON ALLEGEDLY WOULD NOT DEFLATE. THE BALLOON WAS PUNCTURED VIA AN ACCESS THROUGH THE INTERNAL JUGULAR VEIN AND WAS REMOVED OFF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13505589 ↗
• MalfunctionFeb 9, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN IVC FILTER REMOVAL PROCEDURE, THE INTRAVASCULAR BALLOON ALLEGEDLY WOULD NOT DEFLATE. THE BALLOON WAS PUNCTURED VIA AN ACCESS THROUGH THE INTERNAL JUGULAR AND WAS REMOVED OFF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497589 ↗
• InjuryJan 11, 2022Material Frayed; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Frayed; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH FEMORAL VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6ATM. IT WAS FURTHER REPORTED THAT THE PTA BALLOON WAS ALLEGEDLY DETACHED FROM THE CATHETER SHAFT AND THE DETACHED PARTS OF BALLOON WAS ALLEGEDLY DIFFICULT TO REMOVE FROM THE PATIENT. THE PHYSICIAN MANAGED TO PUNCTURE THE BALLOON AND DEVICE FRAGMENTS REMAINED IN THE VESSEL WERE REMOVED FROM THE PATIENT THROUGH SHEATHS. THE STATUS OF THE PATIENT WAS REPORTED AS STABLE.

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

  MAUDE report 13220447 ↗
• MalfunctionNov 16, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE FEMORAL VEIN, THE BALLOON ALLEGEDLY FAILED TO DEFLATE; HOWEVER, MULTIPLE ATTEMPTS ATTEMPTS WERE MADE TO DEFLATE THE BALLOON WITH SYRINGES AND AN INFLATION DEVICE, BUT ALL WERE UNSUCCESSFUL. IT WAS FURTHER REPORTED THAT THE BALLOON WAS DEFLATED BY POPPING IT USING NEEDLE TIPS VIA AN IJ ACCESS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819734 ↗
• InjuryNov 9, 2021Material Frayed; Material Rupture; Unraveled Material; Detachment of Device or Device Component; Material Frayed; Material Rupture; Unraveled Material; 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 THE SHAFT AND WAS STILL INSIDE THE PATIENT IN AN UNKNOWN LOCATION. THE CURRENT STATUS OF THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 12777061 ↗
• MalfunctionSep 21, 2021Deflation Problem; Deflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507603 ↗
• MalfunctionAug 30, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO DEFLATE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12385196 ↗
• InjuryAug 15, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BROKE AND DETACHED. IT WAS FURTHER REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 12322329 ↗
• MalfunctionJul 23, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON DEFLATED SLIGHTLY ENOUGH FOR PHYSICIANS TO BE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12216077 ↗
• MalfunctionJul 15, 2021Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY HAD DIFFICULTY IN RETRACTING THE BALLOON THRU THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171397 ↗
• MalfunctionJul 15, 2021Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY HAD DIFFICULTY IN RETRACTING THE BALLOON THRU THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171331 ↗