Atlas® Gold ATG120244Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741061028), received between Oct 18, 2017 and Oct 22, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ANGIOPLASTY PROCEDURE, THE PTA BALLOON CAPSULE ALLEGEDLY FELL OFF DURING THE OPERATION AND COULD NOT BE REMOVED. IT WAS FURTHER REPORTED THAT THE CAPSULE CANNOT BE CAPTURED THROUGH INTERVENTIONAL TECHNIQUES. REPORTEDLY, THE PATIENT WAS IN THE CARDIAC SURGERY OF THE OPEN THORACIC SURGERY TO TAKE OUT THE BALLOON. THE CURRENT STATUS OF THE PATIENT IS STABLE.

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

  MAUDE report 20506763 ↗
• MalfunctionDec 11, 2023Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 10 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300735 ↗
• MalfunctionNov 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR AN AORTIC VALVE REPLACEMENT, VIA THE FEMORAL ACCESS, THE PTA BALLOON WAS ALLEGEDLY FOUND TO BE PUNCTURED WITH A HOLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129844 ↗
• InjuryOct 20, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE PULMONIC VALVE VIA THE RIGHT JUGULAR VEIN ACCESS, DURING THE FIRST INFLATION PRIOR TO REACHING THE RATED BURST PRESSURE, THE PTA BALLOON ALLEGEDLY RUPTURED BEFORE OR AT 3 ATM AT MOST, AND ALLEGEDLY HAD A SMALL PINPOINT LEAKAGE IN THE DISTAL SHOULDER OF THE BALLOON. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PULMONARY ARTERY DISSECTION AND HAD A PARTIAL RUPTURE OF THE PULMONARY ARTERY THAT CAUSED PERICARDIAL INFUSION. FURTHERMORE, THE PROCEDURE WAS UNABLE TO BE COMPLETED DUE TO THE RISK OF SUBSEQUENT BALLOON INFLATIONS AND THE PROCEDURE WAS ABORTED FOR PATIENT'S SAFETY. REPORTEDLY, THE PATIENT WAS KEPT FOR FORTY-EIGHT HOURS IN THE INTENSIVE CARE UNIT FOR CLOSE MONITORING OF THE PROGRESSIVE PULMONARY ARTERY RUPTURE AND HAD ACTIVITY RESTRICTIONS AT HOME FOR ABOUT TWO TO FOUR WEEKS. HOWEVER, THE PATIENT WAS RECOVERED WELL.

  Patient problems: Pericardial Effusion; Vascular Dissection

  MAUDE report 17974223 ↗
• MalfunctionSep 29, 2023Leak/Splash; Material Rupture; Improper or Incorrect Procedure or Method; Leak/Splash; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A BALLOON VALVULOPLASTY PROCEDURE FOR VALVULAR PULMONIC STENOSIS, THROUGH THE RIGHT JUGULAR VEIN, THE DEVICE ALLEGEDLY HAD A LEAK BETWEEN SHAFT AND BALLOON INTERFACE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17841275 ↗
• MalfunctionFeb 8, 2021Retraction Problem; Unraveled Material; Detachment of Device or Device Component; Retraction Problem; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY DIFFICULT TO BE PULLED BACK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11290979 ↗
• MalfunctionJul 19, 2019Break; Retraction Problem; Material Rupture; Break; Retraction Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG120244 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A RETRACTION PROBLEM AND RUPTURE. THERE WAS ONE PATIENT INVOLVED WITH NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808057 ↗
• MalfunctionOct 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY DETACHED FROM THE CATHETER. REPORTEDLY, THE HEALTH CARE PROVIDER WAS ABLE TO SUCCESSFULLY RETRIEVE THE BALLOON SEGMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6960172 ↗