Atlas® Gold ATG80146Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741060779), received between Feb 14, 2019 and Jan 12, 2023 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2023Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY BROKE OFF INTO THE PATIENT. REPORTEDLY, THE BROKEN BALLOON WAS RETRIEVED FROM THE PATIENT USING AN EQUIPMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16144677 ↗
• MalfunctionNov 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY BURST 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 15866798 ↗
• MalfunctionNov 8, 2022Entrapment of Device; Material Frayed; Material Rupture; Unraveled Material; Entrapment of Device; Material Frayed; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY UNRAVELED. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY CAUGHT IN STENT. REPORTEDLY, BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751468 ↗
• MalfunctionJun 27, 2022Difficult 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 VIA RIGHT LOWER LIMB, THE PTA BALLOON ALLEGEDLY RUPTURED AT THE SECOND INFLATION AROUND 10 TO 12 ATM. IT WAS FURTHER REPORTED THAT THE PTA BALLOON ALLEGEDLY DETACHED FROM THE SHAFT AND WAS NOT ABLE TO BE REMOVED. REPORTEDLY ENDOSCOPIC GRASPERS WAS USED TO REMOVE THE BALLOON OUT OF THE BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14825790 ↗
• MalfunctionFeb 1, 2022Break; Material Frayed; Difficult to Remove; Material Rupture; Unraveled Material; Break; Material Frayed; Difficult to Remove; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH THE RIGHT INTERNAL JUGULAR VEIN, THE PTA BALLOON WAS ALLEGEDLY RUPTURED FROM THE DISTAL PART(TIP). THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13410611 ↗
• MalfunctionNov 2, 2021Material Frayed; Difficult to Remove; Unraveled Material; Material Frayed; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY DIFFICULT TO REMOVE. IT WAS FURTHER REPORTED THAT THE BALLOON CUT AND REMOVED FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12734520 ↗
• MalfunctionSep 28, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538471 ↗
• MalfunctionSep 28, 2021Material Rupture; 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 12538469 ↗
• MalfunctionAug 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER THE PROCEDURE, THE PTA BALLOON ALLEGEDLY GOT DETACHED FROM THE SHAFT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363944 ↗
• MalfunctionJul 14, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164790 ↗
• MalfunctionMay 18, 2021Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING THE ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD RUPTURE AND LEAK ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11839888 ↗
• MalfunctionApr 13, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT POST DILATION OF THE STENT PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655159 ↗
• MalfunctionApr 17, 2020Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL ATG80146 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED RETRACTION PROBLEM AND DETACHMENT OF DEVICE. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE MALE PATIENT IS 55 YEARS OLD AND WEIGHS 250 POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9973397 ↗
• MalfunctionOct 15, 2019Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG80146 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A DEFLATION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT WITH PATIENT STATUS UNKNOWN. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9195163 ↗
• MalfunctionJul 22, 2019Break; Retraction Problem; Break; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT AN ATG80146 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE RETRACTION PROBLEM INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCE. THE AGE, WEIGHT, AND SEX WERE NOT REPORTED FOR THE PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811697 ↗
• InjuryJun 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERIOR VENA CAVA, THE PTA BALLOON ALLEGEDLY DETACHED AND MIGRATED TO THE PULMONARY ARTERY. IT WAS FURTHER REPORTED THAT A STERNOTOMY WAS PERFORMED TO REMOVE THE DETACHED BALLOON. THE PATIENT WAS REPORTED STABLE POST PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8737594 ↗
• MalfunctionApr 15, 2019Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL ATG80146 DILATATION CATHETER EXPERIENCED A DEFLATION ISSUE AND A DETACHMENT OF DEVICE OR COMPONENT. THIS EVENT WAS REPORTED FROM A SINGLE SOURCE. THIS EVENT INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515354 ↗
• MalfunctionFeb 14, 2019Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUBCLAVIAN VEIN, THE PTA BALLOON ALLEGEDLY HAD INFLATION ISSUES. NO FURTHER TREATMENT WAS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8341553 ↗