Atlas® Gold ATG80186Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741060892), received between May 4, 2018 and Jan 31, 2024 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2024Entrapment of Device; Material Rupture; Detachment of Device or Device Component; Entrapment of Device; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY POPPED UP AT NOMINAL PRESSURE. IT WAS FURTHER REPORTED THAT THE BALLOON BECAME ALLEGEDLY DISLODGED AND CAME OFF THE SHAFT AND WAS STUCK IN THE SUBCLAVIAN. REPORTEDLY, THE DEVICE AND INTRODUCER SHEATH WERE NOT REMOVED AS ONE UNIT AND THE BALLOON WAS REMOVED BY DOING A CUT DOWN AND PULLING OUT THE BALLOON WITH SCISSORS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 18612949 ↗
• InjuryMar 10, 2021Break; Difficult to Remove; Material Rupture; Material Deformation; Break; Difficult to Remove; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE THROUGH THE BRACHIOCEPHALIC VEIN, THE DEVICE ALLEGEDLY RUPTURED. THE DOCTOR DEFLATED THE BALLOON AND NOTICED BLOOD ON THE DEVICE. UPON INSPECTION, THE BALLOON WAS FOUND TO BE BADLY DAMAGED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 11449842 ↗
• MalfunctionOct 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY SEPARATED FROM CATHETER. IT WAS FURTHER REPORTED THAT THE DETACHED BALLOON STILL REMAIN IN THE PATIENT. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10659558 ↗
• InjuryAug 10, 2020Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY BROKE INSIDE THE PATIENT AND IT WAS NOT POSSIBLE TO REMOVE THE DEVICE WHICH BROKE AND FORCING OPEN SURGERY TO BE REMOVED. THE PATIENT STATUS WAS UNKNOWN

  Patient problems: Injury

  MAUDE report 10383604 ↗
• MalfunctionJul 15, 2020Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG80186 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED PINHOLE BALLOON RUPTURE AND DETACHMENT. 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 10276622 ↗
• MalfunctionApr 16, 2020Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG80186 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE (B)(6) FEMALE PATIENT WEIGHED (B)(6) .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9967926 ↗
• MalfunctionJul 23, 2019Break; Deflation Problem; Retraction Problem; Break; Deflation Problem; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG80186 PTA BALLOON DILATATION CATHETER ALLEGEDLY WOULD NOT FULLY DEFLATE, HAD DIFFICULTY RETRACTING THROUGH THE SHEATH, AND BROKE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THERE WAS ONE PATIENT INVOLVED WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS A 65-YEAR-OLD FEMALE WHO WEIGHED 140 POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8816691 ↗
• InjuryApr 24, 2019Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS ORIGINALLY REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED ON THE SECOND INFLATION ATTEMPT. IT WAS FURTHER REPORTED THAT MATERIAL FROM THE BALLOON ALLEGEDLY DETACHED. THE DETACHED MATERIAL ALLEGEDLY PROGRESSED FURTHER INTO THE BODY AND FORMED A THROMBUS. THE DETACHED MATERIAL WAS REMOVED BY A SNARE. THERE WAS NO FURTHER REPORTED COMPLICATIONS TO THE PATIENT.

  Patient problems: Thrombus

  MAUDE report 8544546 ↗
• MalfunctionJan 7, 2019Material Frayed; Peeled/Delaminated; Material Rupture; Material Frayed; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE LEFT EXTERNAL ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6ATM DURING THE THIRD INFLATION 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 8224128 ↗
• MalfunctionDec 17, 2018Break; Retraction Problem; Material Rupture; Break; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE LEFT COMMON ILIAC VEIN THE PTA BALLOON ALLEGEDLY RUPTURED AT 10ATM DURING THE FOURTH INFLATION 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 8171466 ↗
• MalfunctionNov 7, 2018Break; Retraction Problem; Material Rupture; Detachment of Device or Device Component; Break; Retraction Problem; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT EXTERNAL ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6ATM DURING THE THIRD INFLATION ATTEMPT. IT WAS FURTHER REPORTED THAT BALLOON GOT STUCK INSIDE THE SHEATH DURING RETRACTION. UPON REMOVING THE BALLOON AND SHEATH TOGETHER AS ONE UNIT, A PARTIAL SEGMENT OF THE BALLOON CATHETER ALLEGEDLY DETACHED BUT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8047853 ↗
• MalfunctionOct 2, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF AN IN STENT RE-STENOSIS, THE PTA BALLOON ALLEGEDLY DETACHED FROM THE CATHETER SHAFT AS THE HEALTH CARE PROVIDER WAS CLEANING THE BALLOON BEFORE INSERTING INTO THE PATIENT FOR THE SECOND INFLATION ATTEMPT. ANOTHER BALLOON WAS PREPPED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Stenosis

  MAUDE report 7927846 ↗
• InjurySep 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY OF AN IN STENT RE-STENOSIS IN THE ILIAC VEIN, THE PTA BALLOON ALLEGEDLY DETACHED FROM THE CATHETER SHAFT DURING AN INFLATION ATTEMPT. REPORTEDLY, THE HEATH CARE PROVIDER (HCP) ATTEMPTED TO RETRIEVE THE DETACHED SEGMENT USING A SNARE DEVICE BUT WAS UNSUCCESSFUL. THE HCP DECIDED TO SEND THE PATIENT TO A LOCAL HOSPITAL E.R. FOR REMOVAL OF THE DETACHED BALLOON SEGMENT. THE PATIENT WAS REPORTED AS ASYMPTOMATIC.

  Patient problems: Stenosis

  MAUDE report 7895167 ↗
• MalfunctionMay 4, 2018Material Frayed; Peeled/Delaminated; Retraction Problem; Detachment of Device or Device Component; Device-Device Incompatibility; Material Frayed; Peeled/Delaminated; Retraction Problem; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DISTAL PORTION OF THE PTA BALLOON ALLEGEDLY DETACHED WHILE POST DILATING A WALL STENT. THE HEALTH CARE PROVIDER USED A SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE DETACHED BALLOON SEGMENT. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY REMOVING THE BALLOON OVER THE WIRE AND THROUGH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7488956 ↗