Atlas® Gold ATG80184Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741060878), received between Mar 7, 2017 and May 6, 2025 — classified as 5 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2025Material Rupture; Material Rupture

  A PATIENT UNDERWENT ANGIOPLASTY PROCEDURE. DURING THE PROCEDURE THE BALLOON ALLEGEDLY BURST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966374 ↗
• MalfunctionDec 1, 2023Peeled/Delaminated; Material Rupture; Peeled/Delaminated; 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 18244611 ↗
• MalfunctionSep 12, 2023Material Frayed; Material Rupture; Material Frayed; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17727882 ↗
• MalfunctionJan 31, 2023Break; Material Rupture; Improper or Incorrect Procedure or Method; Break; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY LEAKED ON THE THIRD INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270816 ↗
• MalfunctionJul 27, 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 SUPERIOR VENA CAVA, THE BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON CAME OFF FROM THE CATHETER. REPORTEDLY, THE PHYSICIAN WAS ABLE TO CUT DOWN AND GRABBED THE BALLOON WITH A CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15109680 ↗
• 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 14510964 ↗
• InjuryDec 23, 2021Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DETACHED INSIDE THE PATIENT FROM CATHETER. IT WAS FURTHER REPORTED THAT THE PATIENT HAD TO HAVE A TRANSVERSE CUT DOWN AT THE LEFT POPLITEAL VEIN TO REMOVE THE DEVICE. THE CURRENT PATIENT STATUS IS UNKNOWN.

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

  MAUDE report 13071343 ↗
• 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 12385185 ↗
• MalfunctionJul 28, 2021Difficult 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 GOT STUCK IN THE INTRODUCER SHEATH WHEN PHYSICIAN ATTEMPT TO REMOVE THE BALLOON FROM THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT PROXIMAL END OF THE BALLOON WAS ALLEGEDLY DETACHED FROM THE CATHETER SHAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236944 ↗
• InjuryMar 18, 2021Break; Retraction Problem; Material Rupture; Unraveled Material; Detachment of Device or Device Component; Break; Retraction Problem; Material Rupture; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY STUCK IN THE SHEATH AND THE BALLOON DETACHED FROM THE SHAFT. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED BY PERFORMING A VENOPLASTY PROCEDURE. THE PATIENT STATUS WAS UNKNOWN.

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

  MAUDE report 11514977 ↗
• MalfunctionMar 16, 2021Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED THAT POST ANGIOPLASTY PROCEDURE THROUGH THE RIGHT COMMON FEMORAL VEIN TO TREAT CENTRAL VENOUS STENOSIS OF THE RIGHT IMMONINATED VENOUS TRUNK, THE BALLOON WAS DEFLATED. HOWEVER, WHEN WITHDRAWING THE BALLOON, THE DEVICE ALLEGEDLY HAD RETRACTION PROBLEM. IT WAS FURTHER REPORTED THAT THE WHOLE DEVICE WAS WITHDRAWN WITH THE INTRODUCER SHEATH AND THE BALLOON AT THE SAME TIME. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11493725 ↗
• MalfunctionNov 11, 2020Break; Retraction Problem; Unraveled Material; Break; Retraction Problem; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY WOULD NO PULL THROUGH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10820995 ↗
• MalfunctionApr 20, 2020Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG80184 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED RETRACTION PROBLEM AND DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9979689 ↗
• MalfunctionJan 15, 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 ATG80184 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE MATERIAL RUPTURE AND DETACHMENT OF DEVICE OR DEVICE COMPONENT, ONE INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. THE MALE PATIENT WAS (B)(6) YEARS OLD AND WEIGHED (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593359 ↗
• MalfunctionJul 23, 2019Break; Retraction Problem; Material Rupture; Break; Retraction Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG80184, PTA BALLOON DILATATION CATHETER, ALLEGEDLY EXPERIENCED BREAK, RETRACTION PROBLEM, AND MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT IS 61 YEARS OF AGE, THE GENDER IS FEMALE; HOWEVER, THE WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8816685 ↗
• InjuryJun 26, 2019Break; Material Rupture; Detachment of Device or Device Component; Break; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE ON THE LEFT BRACHIOCEPHALIC VEIN, THE DEVICE ALLEGEDLY BROKE. ADDITIONALLY, THE BALLOON DETACHED IN THE PATIENT AND HAD TO BE REMOVED THROUGH A SECONDARY PROCEDURE.

  Patient problems: Injury

  MAUDE report 8736608 ↗
• InjuryJun 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 WAS ALLEGEDLY DIFFICULT TO RETRACT. IT WAS FURTHER REPORTED THAT THE PTA BALLOON DETACHED DURING RETRACTION. A SECONDARY PROCEDURE WAS DONE TO REMOVE THE DETACHED BALLOON. THE PROCEDURE WAS COMPLETED USING A NEW BALLOON. THERE WERE NO FURTHER REPORTED COMPLICATIONS.

  Patient problems: Injury

  MAUDE report 8680979 ↗
• MalfunctionNov 29, 2018Material 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 ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS DETACHED FROM THE CATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8118454 ↗
• InjuryOct 17, 2018Deflation Problem; Retraction Problem; Material Rupture; Deflation Problem; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT COMMON ILIAC ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AT RATED BURST PRESSURE. IT WAS FURTHER REPORTED THAT THE BALLOON COULD NOT BE DEFLATED AND HAD DIFFICULTY RETRACTING. A NEEDLE STICK WAS ALLEGEDLY USED TO DEFLATE THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTEDLY ASYMPTOMATIC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7976031 ↗
• MalfunctionMar 7, 2017Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PTA BALLOON CATHETER ALLEGEDLY RUPTURED (ATM UNKNOWN) DURING INFLATION WITHIN A BARE METAL STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6385696 ↗