Atlas® Gold ATG80124Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741060694), received between Apr 25, 2017 and Feb 5, 2026 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Material Rupture

  A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE BY USING THE ATLAS GOLD BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24266038 ↗
• MalfunctionApr 10, 2024Crack; Material Puncture/Hole; Material Rupture; Material Deformation; Crack; Material Puncture/Hole; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUBCLAVIAN VEIN VIA THE RIGHT ARM FISTULA, THE PTA BALLOON ALLEGEDLY HAD A HOLE IN THE GUIDEWIRE LUMEN THROUGH WHICH THE GUIDEWIRE KEPT GOING THROUGH. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077518 ↗
• MalfunctionFeb 12, 2024Difficult 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 AXILLARY GRAFT, THE PTA BALLOON ALLEGEDLY RUPTURED INSIDE THE PATIENT'S BODY. IT WAS FURTHER REPORTED THAT UPON BRINGING THE BALLOON BACK INTO THE SHEATH OVER THE WIRE, THE BALLOON COMPONENT CAUGHT AT THE SHEATH TIP AND THE BALLOON SHAFT ALLEGEDLY BROKE OFF INSIDE THE BODY. FURTHERMORE, THE SHEATH WAS BROUGHT OUT OVER THE WIRE AND WITH THE BALLOON EMBEDDED IN THE SHEATH TIP, THE SHEATH AND THE BALLOON WERE REMOVED AS ONE UNIT. REPORTEDLY, A SNARE WAS USED TO RETRIEVE THE RETAINED PORTION OF THE BALLOON FROM THE PATIENT'S BODY AND PLACED A NEW SHEATH OVER THE WIRE TO FINISH THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18683041 ↗
• MalfunctionMay 8, 2023Entrapment of Device; Unraveled Material; Entrapment of Device; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY GOT STUCK IN THE STENT AT THE TIME OF REMOVAL. THE PROCEDURE WAS COMPLETED BY CHANGING THE GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16884885 ↗
• InjurySep 27, 2022Difficult 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 BALLOON ALLEGEDLY DETACHED FROM THE SHAFT. IT WAS FURTHER REPORTED THAT THE BALLOON WAS DIFFICULT TO BE REMOVED FROM THE PATIENT. REPORTEDLY, THE DEVICE CAUSED OCCLUSION AT THE LEVEL OF THE V. PULMONALIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15493248 ↗
• MalfunctionAug 24, 2022Difficult 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 A STENOSIS OF THE VEIN, THE BALLOON ALLEGEDLY DETACHED FROM THE CATHETER. IT WAS FURTHER REPORTED THAT THE BALLOON WAS UNABLE TO BE RETRIEVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15282187 ↗
• InjuryAug 16, 2022Difficult 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 A STENOSIS OF THE VEIN, THE BALLOON ALLEGEDLY DETACHED FROM THE CATHETER. IT WAS FURTHER REPORTED THAT THE BALLOON WAS UNABLE TO BE RETRIEVED. REPORTEDLY, IT WAS REMOVED BY VENOTOMY PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 15231742 ↗
• MalfunctionApr 1, 2022Difficult 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 BALLOON ALLEGEDLY SEPARATED FROM THE SHAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13974188 ↗
• MalfunctionMar 4, 2021Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11409823 ↗
• MalfunctionJan 8, 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. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY DETACHED FROM THE MAIN STEM OF THE PRODUCT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11138440 ↗
• MalfunctionDec 9, 2020Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH SUPERIOR VENA CAVA, THE BALLOON ALLEGEDLY HAD A TRANSVERSE RUPTURE AND DETACHED FROM THE SHAFT. IT WAS FURTHER REPORTED THAT THE BALLOON WAS RETRIEVED ALONG WITH THE SHEATH AND NO ADDITIONAL INTERVENTION REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10974697 ↗
• MalfunctionJul 21, 2020Material Frayed; Retraction Problem; Material Frayed; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE MALFUNCTION INDICATED THAT MODEL ATG80124 PTA BALLOON DILATATION CATHETER ALLEGEDLY HAD A RETRACTION ISSUE AND FRAYED MATERIAL. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN A MALE PATIENT. AGE AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10300310 ↗
• MalfunctionJul 21, 2020Material Frayed; Retraction Problem; Detachment of Device or Device Component; Material Frayed; Retraction Problem; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG80124 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT, RETRACTION ISSUE AND FRAYED MATERIAL. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE DEVICE WAS USED IN A MALE PATIENT. AGE AND WEIGHT OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10300300 ↗
• InjuryApr 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT ARM FISTULA, THE PTA BALLOON ALLEGEDLY DETACHED FROM THE CATHETER AND IMPEDED BLOOD FLOW UPON REMOVAL OF THE DEVICE. IT WAS FURTHER REPORTED THAT A SNARE DEVICE WAS USED TO RETRIEVE THE DETACHED SEGMENT; HOWEVER, IT WAS UNSUCCESSFUL. THE HEALTH CARE PROVIDER (HCP) USED A STENT TO APPOSE THE DETACHED SEGMENT AGAINST THE VESSEL WALL. REPORTEDLY, ANOTHER BALLOON WAS USED TO DILATE THE STENT AND THE PROCEDURE WAS CONCLUDED. THE PATIENT WAS REPORTEDLY STABLE POST PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9970105 ↗
• MalfunctionApr 16, 2020Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG80124 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE 55 YEAR OLD MALE PATIENT WEIGHED 73 KILOGRAMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968480 ↗
• InjuryMar 26, 2020Retraction 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 AXILLARY VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM DURING INFLATION AND THE BALLOON DETACHED FROM THE CATHETER. IT WAS FURTHER REPORTED THAT UPON REMOVAL, THE BALLOON CATHETER WAS UNABLE TO RETRACT THROUGH THE SHEATH. REPORTEDLY, THE DETACHED SEGMENT WAS SURGICALLY CUT DOWN AND RETRIEVED USING A SNARE DEVICE. THE PATIENT WAS REPORTEDLY STABLE AND DISCHARGED ONE HOUR POST PROCEDURE.

  Patient problems: Injury

  MAUDE report 9886859 ↗
• InjuryOct 31, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC-FEMORAL VENOUS DISTRICT, THE PTA BALLOON ALLEGEDLY DETACHED FROM THE SHAFT WHILE BEING INFLATED. IT WAS FURTHER REPORTED THAT A STENT WAS PLACED IN ORDER TO BLOCK THE ADVANCEMENT OF THE BALLOON IN THE VESSEL. REPORTEDLY, THE FEMORAL VEIN WAS OCCLUDED. IT WAS FURTHER REPORTED THAT ANOTHER PTA BALLOON DILATATION CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED FURTHER COMPLICATIONS.

  Patient problems: Device Embedded In Tissue or Plaque; Occlusion

  MAUDE report 9261450 ↗
• MalfunctionMay 9, 2018Break; Retraction Problem; Detachment of Device or Device Component; Break; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PTA BALLOON DILATATION, THE BALLOON COMPONENT DETACHED OFF THE CATHETER. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7501214 ↗
• MalfunctionMay 2, 2018Break; Material Deformation; Packaging Problem; Break; Material Deformation; Packaging Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE DISTAL END OF THE INFLATION HUB ALLEGEDLY BROKE. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7480081 ↗
• MalfunctionOct 30, 2017Retraction 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 OF A RIGHT CENTRAL OCCLUSION, AN ALLEGED PINHOLE RUPTURE OCCURRED AND WAS SUBSEQUENTLY DIFFICULT TO RETRACT FROM THE SHEATH. IT WAS FURTHER REPORTED THAT UPON ATTEMPTS TO RETRACT THE BALLOON THROUGH THE SHEATH, THE CATHETER SHAFT ALLEGEDLY DETACHED. THE BALLOON CATHETER AND SHEATH WERE REMOVED TOGETHER AS ONE UNIT. REPORTEDLY, ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6989160 ↗
• MalfunctionApr 25, 2017Break; Retraction Problem; Detachment of Device or Device Component; Break; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT FOLLOWING AN ANGIOPLASTY PROCEDURE IN A SUBCLAVIAN CENTRAL STENOSIS, THE PTA BALLOON CATHETER ALLEGEDLY COULD NOT BE RETRACTED THROUGH THE 7FR SHEATH. THE BALLOON AND SHEATH WERE REMOVED AS A SINGLE UNIT AND ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6521069 ↗