Atlas® Gold ATG80126Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741060717), received between Oct 15, 2019 and Jun 27, 2024 — classified as 1 injury, 7 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.

• MalfunctionJun 27, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, IT WAS NOTICED THAT THE THREE CODES WITH THE INFORMATION ALLEGEDLY DOES NOT HAVE BARCODES. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19621538 ↗
• MalfunctionJun 27, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, IT WAS NOTICED THAT THE THREE CODES WITH THE INFORMATION ALLEGEDLY DOES NOT HAVE BARCODES. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19621511 ↗
• MalfunctionMay 9, 2023Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE OUTSIDE AND INSIDE OF THE DEVICE PACKAGE WAS ALLEGEDLY FOUND FOLDED UPON DELIVERY. IT WAS FURTHER REPORTED THAT THE STERILITY OF THE DEVICE WAS AFFECTED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16897013 ↗
• InjuryMar 23, 2023Deflation Problem; Difficult to Remove; Material Rupture; Failure to Advance; Detachment of Device or Device Component; Device-Device Incompatibility; Deflation Problem; Difficult to Remove; Material Rupture; Failure to Advance; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, BALLOON ALLEGEDLY GOT STUCK IN THE PATIENT. IT WAS FURTHER REPORTED THAT BALLOON ALLEGEDLY DISCONNECTED FROM THE CATHETER AND SINCE IT WAS ATTACHED TO THE FISTULA THE CATHETER WAS CUT TO PULL IT THRU. IT WAS FURTHER REPORTED THAT THE BALLOON WAS RUPTURED AND CATHETER WAS STILL ON THE WIRE. REPORTEDLY, DETACHED SEGMENT WAS REMOVED USING SNARE AND FEMORAL ACCESS WAS GAINED TO PULL THE BALLOON AND CATHETER. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 16601912 ↗
• MalfunctionNov 25, 2021Fluid/Blood Leak; Material Frayed; Leak/Splash; Material Rupture; Fluid/Blood Leak; Material Frayed; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ARTERIOVENOUS FISTULA ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY APPEARED TO BE LEAKING UNDER FLUOROSCOPY. IT WAS FURTHER REPORTED THAT THE DEVICE WAS DEFLATED AND REMOVED IMMEDIATELY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12874564 ↗
• MalfunctionJul 17, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG80126 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. AGE, WEIGHT, AND GENDER OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10287578 ↗
• MalfunctionApr 16, 2020Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG80126 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED AN INFLATION ISSUE AND MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE WEIGHT OF THE (B)(6) YEAR OLD FEMALE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968394 ↗
• MalfunctionOct 15, 2019Leak/Splash; Peeled/Delaminated; Material Rupture; Leak/Splash; Peeled/Delaminated; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG80126 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED LEAK, PEELED LAYER, AND MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. THE FEMALE PATIENT IS 68 YEARS OLD AND WEIGHS 83 KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9195121 ↗