Atlas® Gold ATG120164Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741060823), received between Aug 24, 2017 and May 19, 2025 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2025Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS CATHETER TO TREAT ILIAC VEIN STENOSIS. DURING THE BALLOON REMOVAL, THE BALLOON COULD NOT BE GATHERED AND RETRIEVED NORMALLY AT FIRST. AFTER CONTINUING TO ATTEMPT BALLOON REMOVAL, THE BALLOON RUPTURED AND WAS SUBSEQUENTLY REMOVED WITH A RETRIEVAL DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 22042634 ↗
• MalfunctionJul 2, 2024Break; 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 IN THE PATIENT'S LEFT ILIAC VEIN VIA THE LEFT FEMORAL VEIN ACCESS, THE PTA BALLOON WAS ALLEGEDLY FAILED TO FILL PROPERLY. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGEDLY A DISCONNECTION BETWEEN THE BALLOON AND THE DELIVERY SYSTEM. FURTHERMORE, THE BALLOON AND THE DELIVERY SYSTEM WERE REMOVED FROM THE BODY TOGETHER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19658740 ↗
• InjuryApr 27, 2023Difficult 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 VIA SUBCLAVIAN VEIN AND RIGHT INNOMINATE VEIN, THE PTA BALLOON ALLEGEDLY SEPARATED FROM THE CATHETER INSIDE THE PATIENT'S VEIN. IT WAS FURTHER REPORTED THAT SNARE WAS USED TO RETRIEVE THE BALLOON. REPORTEDLY THE BALLOON HAD TO BE PUSHED TILL THE ILIAC AND A NEW PUNCTURE WAS MADE THROUGH PATIENT'S FEMORAL TO REMOVE THE BALLOON. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 16822798 ↗
• MalfunctionMar 23, 2023Difficult 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, THE BALLOON ALLEGEDLY BURST. IT WAS FURTHER REPORTED THAT BALLOON WAS ALLEGEDLY DIFFICULT TO REMOVE FROM THE INTRODUCER SHEATH. REPORTEDLY, THE BALLOON WAS ALLEGEDLY ALSO DETACHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16598507 ↗
• InjuryMar 1, 2023Difficult 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, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT WHILE RETRACTING BALLOON THROUGH THE INTRODUCER SHEATH, THE BALLOON GOT STUCK AT THE DISTAL TIP OF SHEATH. REPORTEDLY, THE DEVICE WAS REMOVED. 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 16457918 ↗
• MalfunctionNov 22, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD A DEFLATION ISSUE. IT WAS FURTHER REPORTED THAT BALLOON WAS PUNCTURED WITH THE TAIL END OF THE EXTRA STIFF WIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15841675 ↗
• MalfunctionJun 8, 2022Material 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 WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON DISTAL PART WAS ALLEGEDLY DETACHED FROM THE PROXIMAL ENDS OF 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 14629912 ↗
• MalfunctionApr 4, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC VEIN, THE PTA BALLOON ALLEGEDLY HAD INFLATION AND DEFLATION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13995524 ↗
• MalfunctionMar 14, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY WOULD NOT DEFLATE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13757778 ↗
• MalfunctionNov 2, 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, THE BALLOON ALLEGEDLY RUPTURED AND BALLOON COULD NOT BE RETRACTED EASILY INTO THE SHEATH. IT WAS FURTHER REPORTED THAT THE CATHETER BROKE AND THE DETACHED BALLOON WAS SNARED USING A GUIDEWIRE AND MOVED IN TO THE GROIN OF THE PATIENT. THEREFORE, THE ENTIRE BALLOON AND INTRODUCER SHEATH WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12736140 ↗
• MalfunctionSep 27, 2021Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Device Dislodged or Dislocated; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT NOMINAL PRESSURE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY DIFFICULT TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12531311 ↗
• MalfunctionAug 10, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD DEFLATION ISSUE. THE PHYSICIAN PIERCED THE BALLOON WITH THE GUIDE AND PULLED IT OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12299201 ↗
• MalfunctionOct 26, 2020Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG120164 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ONE REPORTED MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE AGE, SEX AND WEIGHT OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10736570 ↗
• MalfunctionOct 26, 2020Unraveled Material; Device Contamination with Chemical or Other Material; Packaging Problem; Unraveled Material; Device Contamination with Chemical or Other Material; Packaging Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG120164 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED PACKAGING PROBLEM, UNRAVELED MATERIAL, AND FOREIGN MATERIAL. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10736525 ↗
• MalfunctionApr 20, 2020Break; Retraction Problem; Failure to Advance; Detachment of Device or Device Component; Break; Retraction Problem; Failure to Advance; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG120164 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED FAILURE TO ADVANCE AND DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE WEIGHT OF THE (B)(6) YEAR OLD MALE IS (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9979795 ↗
• MalfunctionJul 23, 2019Material 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 ATG120164 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND A DETACHMENT OF DEVICE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT WAS REPORTED AS A 66-YEAR-OLD MALE WHOSE WEIGHT WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8816373 ↗
• MalfunctionDec 21, 2018Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN ILIOFEMORAL ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED ON THE INITIAL INFLATION ATTEMPT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189383 ↗
• MalfunctionJul 31, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN PRE-EXISTING STENT, THE PTA BALLOON ALLEGEDLY RUPTURED NEAR THE PROXIMAL SHOULDER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7736374 ↗
• MalfunctionJul 10, 2018Retraction 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 ILIAC VEIN AND INFERIOR VENA CAVA, THE PTA BALLOON ALLEGEDLY RUPTURED ON THE FIRST INFLATION ATTEMPT. ANOTHER PTA BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7675507 ↗
• MalfunctionJul 10, 2018Break; Retraction Problem; Material Rupture; Detachment of Device or Device Component; Break; Retraction Problem; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC VEIN AND INFERIOR VENA CAVA, THE PTA BALLOON ALLEGEDLY RUPTURED ON THE FIRST INFLATION ATTEMPT. ANOTHER PTA BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7675001 ↗
• MalfunctionJul 6, 2018Retraction 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 ILIAC VEIN AND INFERIOR VENA CAVA, THE PTA BALLOON ALLEGEDLY RUPTURED ON THE FIRST INFLATION ATTEMPT. THERE WAS REPORTEDLY DETACHED MATERIAL AND RETRACTION ISSUES. ANOTHER PTA BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7668063 ↗
• MalfunctionJul 6, 2018Retraction 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 ILIAC VEIN AND INFERIOR VENA CAVA, THE PTA BALLOON ALLEGEDLY RUPTURED ON THE FIRST INFLATION ATTEMPT. ANOTHER PTA BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7667882 ↗
• MalfunctionJul 6, 2018Retraction 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 ILIAC VEIN AND INFERIOR VENA CAVA, THE PTA BALLOON ALLEGEDLY RUPTURED ON THE FIRST INFLATION ATTEMPT. ANOTHER PTA BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7667807 ↗
• MalfunctionMay 22, 2018Retraction 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 RIGHT COMMON ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED DURING POST STENT DILATATION. IT WAS FURTHER REPORTED THAT AN ALTERNATE ACCESS SITE WAS USED TO REMOVE THE BALLOON. ANOTHER PTA BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7532221 ↗
• MalfunctionAug 24, 2017Retraction Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Retraction Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC VEIN, THE PTA BALLOON ALLEGEDLY DETACHED FROM THE CATHETER SHAFT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6817394 ↗