Atlas® Gold ATG80142Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741060731), received between May 15, 2018 and Jun 22, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 22, 2023Break; Deflation Problem; Break; Deflation Problem

  IT WAS REPORTED THAT DURING DILATATION IN THE AREA OF THE BRACHIO-CEPHALIC VEIN LEADING INTO THE SUPERIOR VENA CAVA, AN AREA OF VERY HARD STENOSIS CAUSED THE BALLOON TO BE ALLEGEDLY CAUGHT IN THE STENOSIS AND THE INTIMA OF THE VEIN, WHILST THE INFLATION OF THE BALLOON CAUSED THE BALLOON TO PARTIALLY SLIP OFF OF THE BALLOON CATHETER. IT WAS FURTHER REPORTED THAT THE BALLOON DID NOT DISLODGE, BUT ALLEGEDLY FAILED TO DEFLATE WHEN NEGATIVE PRESSURE WAS APPLIED VIA THE INFLATION DEVICE. REPORTEDLY, A GUIDEWIRE WAS GUIDED BEHIND AND ANOTHER BALLOON WAS INFLATED BEHIND THE PTA BALLOON IN ORDER TO DEFLATE IT VIA EXTERNAL PRESSURE. THE CATHETER INCLUDING ALL BALLOON MATERIAL WAS REMOVED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17180912 ↗
• MalfunctionMar 4, 2023Break; Inflation Problem; Difficult to Remove; Unraveled Material; Detachment of Device or Device Component; Material Deformation; Break; Inflation Problem; Difficult to Remove; Unraveled Material; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DID NOT EXPAND AND THE SHAPE OF THE BALLOON WAS WEIRD. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY IN RETRACTING THE DEVICE THRU THE INTRODUCER SHEATH. REPORTEDLY, THE BALLOON ALLEGEDLY DETACHED AND HAIR STRINGS WAS NOTED AROUND THE BALLOON. THERE WAS NO REPORTED PATENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483443 ↗
• MalfunctionAug 30, 2022Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15318862 ↗
• MalfunctionFeb 16, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ALLEGEDLY AN EXPIRED PRODUCT WAS USED IN THE PATIENT DURING AN ANGIOPLASTY PROCEDURE IN LEFT FEMORAL ARTERY. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11330975 ↗
• MalfunctionOct 26, 2020Deflation Problem; Material Deformation; Deflation Problem; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL ATG80142 PTA BALLOON DILATATION CATHETER ALLEGEDLY FAILED TO DEFLATE AND KINKED. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. A (B)(6) YEARS OLD FEMALE PATIENT WEIGHS (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10732422 ↗
• InjurySep 28, 2020Material 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 LEFT UPPER EXTREMITY, THE PTA BALLOON ALLEGEDLY RUPTURED AND DETACHED. IT WAS FURTHER REPORTED THAT THE DETACHED BALLOON WAS REMOVED WITH A SNARE RETRIEVAL KIT. CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10592490 ↗
• MalfunctionJul 16, 2020Break; Unraveled Material; Detachment of Device or Device Component; Break; Unraveled Material; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL ATG80142 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE COMPONENT, BREAK AND UNRAVELED MATERIAL. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10286804 ↗
• MalfunctionMay 15, 2018Break; Peeled/Delaminated; Retraction Problem; Break; Peeled/Delaminated; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUBCLAVIAN VEIN, THE PTA BALLOON WAS UNABLE TO BE RETRACTED THROUGH THE SHEATH AFTER THE SECOND INFLATION/DEFLATION ATTEMPT. THE PROCEDURE WAS CONCLUDED, AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7515747 ↗