Atlas® Gold ATG120146Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741060786), received between Mar 6, 2017 and Dec 11, 2024 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY COULD NOT BE INFLATED NORMALLY WHEN IT REACHED THE STANDARD PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20900410 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST AN ANGIOPLASTY PROCEDURE IN THE ILIAC VEIN, IT WAS NOTED THAT THE PATIENT ALLEGEDLY EXPERIENCED THROMBUS. REPORTEDLY, THE THROMBUS WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20264701 ↗
• MalfunctionNov 22, 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 IN THE LEFT ILIAC, AFTER THE INFLATION WHEN TRYING TO REMOVE THE SHEATH, THE DEVICE ALLEGEDLY MET SOME RESISTANCE, AND THE PTA BALLOON WAS ALLEGEDLY SHEARED OFF THE SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON WAS TRIED TO BE SNARED BUT WAS UNSUCCESSFUL. REPORTEDLY, THE BALLOON WAS ABLE TO STUCK OUT WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18189827 ↗
• InjurySep 15, 2023Entrapment of Device; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Entrapment of Device; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA LEFT FEMORAL VEIN, THE PTA BALLOON WAS BURST WHEN THE PRESSURE WAS INCREASED. IT WAS FURTHER REPORTED THAT THE BALLOON BODY WAS ALLEGEDLY UNABLE TO BE RETRACTED. UPON REMOVAL, DELIVERY ROD WAS FOUND BUT BODY OF THE BALLOON WAS LEFT IN THE BODY OF THIS PATIENT. REPORTEDLY, THE RIGHT FEMORAL VEIN WAS PUNCTURED TO PREVENT THE BALLOON BODY FROM FLOATING TOWARDS THE HEART AND A BALLOON WAS USED TO CLOSE THE OPENING OF THE LEFT COMMON ILIAC VEIN AND THE BALLOON BODY WAS DRAGGED FROM THE LEFT INSERTION SITE FOR MULTIPLE TIMES BUT ALL FAILED. FURTHERMORE, THE STENT WAS TRAVERSED FROM THE RIGHT INSERTION SITE AND RELEASED SO THAT THE BALLOON BODY WAS APPOSED BETWEEN THE TUBING WALL AND STENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 17753923 ↗
• InjuryMay 24, 2023Material 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 AND THE RUPTURED BALLOON FELL INTO THE FEMORAL VEIN. IT WAS FURTHER REPORTED THAT THE INCISION OF THE FEMORAL VEIN WAS MADE TO REMOVE THE RUPTURED BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 16990916 ↗
• MalfunctionNov 8, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO A ANGIOPLASTY PROCEDURE, THE DEVICE PACKAGE ALLEGEDLY PEELED AND BREACH WAS FOUND WITH THE PRIMARY PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15750637 ↗
• MalfunctionDec 30, 2021Material Rupture; 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 13123271 ↗
• MalfunctionDec 24, 2021Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH RIGHT INTERNAL JUGULAR VEIN, THE PTA BALLOON ALLEGEDLY HAD A PIN HOLE RUPTURE AFTER FIVE INFLATIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13083297 ↗
• MalfunctionNov 17, 2021Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED UNDER THE WORKING PRESSURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833700 ↗
• MalfunctionJul 29, 2021Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY LEAKED AT PROXIMAL END. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12245213 ↗
• InjuryMar 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE PELVIC AREA, THE PTA BALLOON ALLEGEDLY DETACHED DURING DILATATION OF A VENOUS STENT. IT WAS FURTHER REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO RECOVER THE DETACHED BALLOON SEGMENT BUT WERE UNSUCCESSFUL. THE PATIENT WAS SENT TO VASCULAR SURGERY TO SURGICALLY REMOVE THE DETACHED SEGMENT. THERE WAS NO REPORTED PATIENT INJURY POST SURGICAL EXTRACTION OF THE BALLOON SEGMENT

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 8437627 ↗
• MalfunctionMar 6, 2017Loss of or Failure to Bond; Retraction Problem; Detachment of Device or Device Component; Loss of or Failure to Bond; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DETACHED FROM THE CATHETER AT 18 ATM. REPORTEDLY, THE DETACHED BALLOON GOT CAUGHT ON THE GUIDE WIRE DURING RETRACTION. THE SHEATH, BALLOON, AND GUIDE WIRE WERE REMOVED AS A SINGLE UNIT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6380080 ↗