Atlas® Gold ATG80144Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 00801741060755), received between Mar 28, 2017 and Aug 13, 2026 — classified as 31 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (51 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 105 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Material Rupture

  A patient underwent a percutaneous transluminal angioplasty procedure using the Atlas Gold balloon catheter. During the procedure, the balloon catheter was allegedly ruptured. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50231616 ↗
• InjuryAug 5, 2026Material Rupture; Detachment of Device or Device Component

  On (b)(6) 2026, a patient underwent an angioplasty procedure using an Atlas Gold PTA balloon. During the procedure, a pinhole rupture of the balloon was noted, and the balloon subsequently degloved from the catheter shaft. As a result, the balloon separated from the shaft and remained within the patient. Furthermore, the patient was sent to ER and snared out of the pulmonary artery. The detached balloon was snared via femoral access site. The current status of the patient was unknown.

  Patient problems: Foreign Body In Patient

  MAUDE report 50137666 ↗
• MalfunctionDec 30, 2025Deflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Improper or Incorrect Procedure or Method

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ESOPHAGEAL DILATATION PROCEDURE BY USING AN ATLAS GOLD BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON ALLEGEDLY FAILED TO FULLY DEFLATE AS INTENDED. AS A RESULT, THE CATHETER HAD TO BE REMOVED WHILE PARTIALLY INFLATED, CAUSING SOME PATIENT DISTRESS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919801 ↗
• MalfunctionOct 21, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY INVOLVING BALLOON INFLATION, THE OPERATOR OBSERVED THAT THE BALLOON WAS LEAKING WHILE BEING INFLATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345599 ↗
• MalfunctionSep 23, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS GOLD FOR FISTULOPLASTY INTENT STENOSIS VENOVO. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY BURST. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23119694 ↗
• MalfunctionSep 23, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS GOLD FOR FISTULOPLASTY INTENT STENOSIS VENOVO. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY BURST. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23119556 ↗
• MalfunctionJul 17, 2025Difficult to Remove; Material Deformation; Material Split, Cut or Torn; Difficult to Remove; Material Deformation; Material Split, Cut or Torn

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS GOLD PTA BALLOON CATHETER. POST THE PROCEDURE, BALLOON GOT CAUGHT AT THE TIP OF THE SHEATH AND COULD NOT BE REMOVED. REPORTEDLY, THERE WAS STRONG RESISTANCE, SO REMOVED THE SHEATH AND INSERTED A NEW SHEATH TO CONTINUE THE TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529222 ↗
• MalfunctionJun 24, 2025Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS GOLD PTA BALLOON CATHETER. DURING THE PROCEDURE, THE CIRCULAR RELIEF ON THE SURFACE OF THE BALLOON THAT HOOKED WITH THE STENT IN THE VESSEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22313115 ↗
• MalfunctionJun 2, 2025Material Rupture; Material Rupture

  IN (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING AN ATLAS GOLD PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOONS WERE ALLEGEDLY NOT INFLATED PROPERLY. IT WAS FURTHER REPORTED THAT THEY ARE LEAKING SALINE OR CONTRACT OUT OF THE DISTAL END OF THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123519 ↗
• MalfunctionJun 2, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IN (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING AN ATLAS GOLD PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOONS WERE ALLEGEDLY NOT INFLATED PROPERLY. IT WAS FURTHER REPORTED THAT THEY ARE LEAKING SALINE OR CONTRACT OUT OF THE DISTAL END OF THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122106 ↗
• MalfunctionFeb 4, 2025Deflation Problem; Difficult to Remove; Material Deformation; Deflation Problem; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DID NOT DEFLATE AFTER INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21302040 ↗
• MalfunctionOct 9, 2024Material Frayed; Material Rupture; Material Deformation; Material Frayed; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA ARTERIOVENOUS ENDOVASCULAR FISTULA ANASTOMOSIS, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AND LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20405432 ↗
• MalfunctionAug 12, 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 RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY CAME OFF THE DELIVERY SYSTEM IN A PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19959227 ↗
• MalfunctionJul 23, 2024Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED ON THIRD INFLATION. IT WAS FURTHER REPORTED THAT THE PTA BALLOON ALLEGEDLY DETACHED AT THE PROXIMAL SIDE OF THE CATHETER AND PROLAPSED OVER THE END. REPORTEDLY, ALL THE BROKEN PARTS OF THE BALLOON WERE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804485 ↗
• InjuryJul 9, 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 SUBCLAVIAN/INTERNAL JUGULAR VEIN STENOSIS, THE PTA BALLOON WAS ALLEGEDLY COMPLETELY DETACHED UPON REMOVAL. IT WAS FURTHER REPORTED THAT THE DETACHED PART OF THE BALLOON WAS LOST INSIDE THE PATIENT'S BODY AND WAS ALLEGEDLY UNABLE TO FIND OR TO BE RETRIEVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19701487 ↗
• InjuryJul 8, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERIOR VENA CAVA VIA LEFT ARM FISTULA, THE PTA BALLOON ALLEGEDLY WOULD NOT DEFLATE. IT WAS FURTHER REPORTED THAT AN ADDITIONAL ACCESS WAS ALLEGEDLY MADE THROUGH A VESSEL THAT WAS NEXT TO THE BALLOON WITH ANOTHER CATHETER TO POP THE BALLOON. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 19687683 ↗
• MalfunctionJun 18, 2024Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE SHIPPING PACKAGE WAS ALLEGEDLY FOLDED IN HALF AND THE PRODUCT WAS ALLEGEDLY FOUND TO BE FOLDED AND DAMAGED AS WELL. IT WAS FURTHER REPORTED THAT THE PRODUCT PACKAGE WAS ALLEGEDLY NOT SEALED SHUT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19556287 ↗
• MalfunctionJun 12, 2024Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE PATIENT'S FOREARM VEIN OF ENDOVASCULAR ARTERIOVENOUS FISTULA ANASTOMOSIS VIA THE LEFT-SIDED APPROACH, THE PTA BALLOON ALLEGEDLY BROKE AND LEAKED DURING THE OPERATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525524 ↗
• MalfunctionApr 16, 2024Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, IT WAS FOUND THAT EXPIRY DATE IN THE LABEL WAS ALLEGEDLY WRONG. IT WAS FURTHER REPORTED THAT THE EXPIRY DATE PROVIDED ON THE LABEL WAS DIFFERENT FROM THE EXPIRY DATE PROVIDED ON SAP PROVIDED EXPIRY DATE WAS DIFFERENT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113863 ↗
• InjuryMar 4, 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, THE PTA BALLOON ALLEGEDLY SHEARED OFF SHAFT WHEN REMOVING IT. IT WAS ALSO REPORTED THAT THE PTA BALLOON ALLEGEDLY HAD DIFFICULTY IN REMOVING. IT WAS FURTHER REPORTED THAT THE PHYSICIAN HAD TO DO A CUT-DOWN ON THE VEIN TO REMOVE THE BALLOON. THE CURRENT STATUS OF THE PATIENT IS REPORTED TO BE STABLE.

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

  MAUDE report 18824351 ↗
• MalfunctionDec 21, 2023Break; Material Frayed; Leak/Splash; Break; Material Frayed; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC VEIN, THE WATER WAS ALLEGEDLY NOTED TO BE LEAKING BETWEEN THE BALLOON AND THE TUBE BODY UNDER NORMAL PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370633 ↗
• MalfunctionAug 29, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUBCLAVIAN VEIN, THE DEVICE ALLEGEDLY HAD A STEADY STREAM OF AIR BUBBLES WHEN PULLED NEGATIVE. REPORTEDLY BALLOON WAS TAKEN OUT OF THE PATIENT AND FINISHED THE CASE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643227 ↗
• InjuryJul 14, 2023Entrapment of Device; Difficult to Remove; Material Rupture; Unraveled Material; Detachment of Device or Device Component; Entrapment of Device; Difficult to Remove; Material Rupture; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AND SEPARATED FROM THE CATHETER, WHICH WAS LEFT INSIDE THE PATIENT'S BODY. IT WAS FURTHER REPORTED THAT THE BALLOON WAS DIFFICULT TO REMOVE THROUGH THE SHEATH. IT WAS ALSO REPORTED THAT THE DETACHED BALLOON WAS TRIED TO BE REMOVED USING A BASKET, BUT IT WAS HARD TO SEE UNDER THE ANGIOGRAM DUE TO THE BALLOON MATERIAL. REPORTEDLY, A STENT WAS USED TO ATTACH IT TO THE VESSEL WALL IN THE PATIENT'S BODY SO THAT THE BALLOON COULD NO LONGER BE MOVED. FURTHER, A THREAD-LIKE MATERIAL WAS ALLEGEDLY FOUND AT THE END OF THE CATHETER UPON REMOVAL. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 17327687 ↗
• MalfunctionJun 23, 2023Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY SEPARATED FROM THE SHAFT AND STARTED MIGRATING. REPORTEDLY, IT HAD TO BE STENTED IN PLACE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189994 ↗
• InjuryMay 4, 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 A ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY SEPARATED FROM THE SHAFT. IT WAS FURTHER REPORTED THAT BALLOON ALLEGEDLY BURST IN CEPHALIC ARCH. REPORTEDLY, THE BALLOON WAS DIFFICULT TO REMOVE FROM INTRODUCER SHEATH AND REMOVED A ONE UNIT. A DISSECTION OF THE VENOTOMY SITE TO REMOVE BALLOON WAS DONE WITH SUBSEQUENT CLOSURE AND PROCEDURE WAS COMPLETED THROUGH NEW VENOTOMY SITE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 16866136 ↗