Atlas® Gold ATG120186Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741060908), received between Oct 15, 2018 and May 1, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 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, WHEN THE DOCTOR STARTED TO INFLATE, THE PTA BALLOON ALLEGEDLY HAD ISSUES IN INFLATION, AND SUDDENLY THE PRESSURE WAS DROPPED, AND THEN FOUND THE BLOOD IN THE INFLATION DEVICE. IT WAS FURTHER REPORTED THAT, WHEN THE DOCTOR MOVED THE CATHETER, BALLOON MATERIAL WAS APART FROM THE CATHETER AND ALLEGEDLY FELL DOWN INTO THE RIGHT ATRIUM. REPORTEDLY, A SNARE DEVICE AND A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON WERE USED TO REMOVE THE BALLOON MATERIAL LEFT INSIDE THE PATIENT'S BODY WHEN THE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19227047 ↗
• 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, THE PTA BALLOON ALLEGEDLY RUPTURED BY RETRACTION OF THE BALLOON. IT WAS FURTHER REPORTED THAT DURING MANUAL RETRACTION OF THE BALLOON DOWN FROM THE VENA CAVA TO THE ILIAC VEIN, THERE WAS RESISTANCE, AND THE BALLOON WAS FOUND TO BE COMPLETELY SEPARATED FROM THE SHAFT. REPORTEDLY, THE BALLOON WAS RETRACTED COMPLETELY BY A SNARE OUT OF PATIENT'S BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18683404 ↗
• InjurySep 6, 2022Deflation Problem; Entrapment of Device; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Deflation Problem; Entrapment of Device; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH RIGHT FEMORAL VEIN, THE BALLOON WAS ALLEGEDLY RUPTURED AND SHEARED OFF THE CATHETER. IT WAS FURTHER REPORTED THAT THE BALLOON CATHETER WAS ALLEGEDLY PREPPED OUTSIDE THE BODY. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY FAILED TO DEFLATE DESPITE SEVERAL ATTEMPTS AND COULD NOT BE WITHDRAWN FROM THE SHEATH. REPORTEDLY, THE BALLOON CATHETER SHEARED OFF THE CATHETER INSIDE THE PATIENT AND WAS STUCK IN THE COMMON FEMORAL VEIN. SURGICAL REMOVAL OF THE BALLOON WAS PERFORMED TO REMOVE THE BALLOON. THE CURRENT STATUS OF THE PATIENT WAS NOT KNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 15359185 ↗
• InjuryJul 5, 2022Entrapment 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 IN THE LEFT COMMON ILIAC VEIN, THE BALLOON WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON MEMBRANE BECAME ENTANGLED AND WEDGED IN THE IN THE VESSEL IN SUCH A WAY THAT EVEN WITH FURTHER DEFLATION, TWISTING AND PULLING OF THE BALLOON CATHETER, IT COULD NOT BE REMOVED FROM THE BALLOON CATHETER COULD NOT BE REMOVED FROM THE PATIENT WITH THE USUAL AMOUNT OF FORCE. REPORTEDLY, THE BALLOON WAS REMOVED UNDER MASSIVE THE BALLOON MEMBRANE DETACHED FROM THE CATHETER AND REMAINED ON THE GUIDE WIRE IN THE PATIENT. IT WAS FURTHER REPORTED THAT THE OPEN SURGERY VIA COMMON FEMORAL VEIN WAS REQUIRED TO REMOVE DETACHED SEGMENT FROM PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 14913477 ↗
• InjuryOct 15, 2018Retraction 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 PELVIC VEINS, THE PTA BALLOON ALLEGEDLY HAD ISSUES RETRACTING AND SEQUENTIALLY DETACHED. A STENT WAS USED TO PIN THE DETACHED BALLOON MATERIAL TO THE VESSEL WALL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7967917 ↗