Atlas® Gold ATG80166Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00801741060830), received between Oct 11, 2016 and Jan 9, 2026 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Break; Leak/Splash; Material Rupture

  ON (B)(6) 2025, A 62-YEAR-OLD FEMALE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE FOR CENTRAL VEIN STENOSIS IN FEMORAL VEIN USING THE ATLAS GOLD PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY LEAKED FROM THE TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017288 ↗
• MalfunctionSep 9, 2025Break; Deflation Problem; Difficult to Remove; Unraveled Material; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Break; Deflation Problem; Difficult to Remove; Unraveled Material; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS GOLD PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY DID NOT DEFLATE. IT WAS FURTHER REPORTED THAT THE INFLATED BALLOON HAD SHIFTED ON THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003054 ↗
• MalfunctionMay 6, 2025Material Rupture; Material Rupture

  A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE. IT WAS FOUND THAT THE BALLOON WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966376 ↗
• MalfunctionMar 26, 2025Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21695503 ↗
• MalfunctionApr 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, BALLOON WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT BLOOD WAS ALLEGEDLY FOUND IN THE SHAFT AFTER DEFLATING THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16805886 ↗
• InjuryFeb 11, 2023Difficult 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 A VENOUS ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED ILIACALLY ON THE RIGHT AT LESS THAN 10 ATM PRESSURE. IT WAS FURTHER REPORTED THAT BECAUSE OF THE PROXIMAL ATTACHMENT AND GIVING SOME TRACTION, CONTRAST RESIDUE CAME OUT AND THE ENTIRE BALLOON OF THE SHAFT ALLEGEDLY GOT TORN OFF. REPORTEDLY, THE BALLOON PART STUCK SOMEWHERE TO THE RIGHT ILIAC. SNARE DEVICE WAS USED TO REMOVE THE ENTIRE BALLOON COMPONENT VIA THE RIGHT INTERNAL JUGULAR VEIN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 16359375 ↗
• MalfunctionNov 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DETACHED. THE DETACHED PART WAS RETRIEVED BY SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15841485 ↗
• MalfunctionSep 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15500306 ↗
• MalfunctionJul 15, 2021Material 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 DETACHED WHILE INFLATING IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12172014 ↗
• MalfunctionDec 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY DETACHED FORM CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11018376 ↗
• MalfunctionOct 26, 2020Material Frayed; Material Rupture; Material Frayed; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG80166 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE AND MATERIAL FRAYED. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE PATIENT WAS REPORTED AS A (B)(6) YEAR-OLD FEMALE WEIGHING (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10737100 ↗
• MalfunctionOct 26, 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 ATG80166 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE AND DEVICE DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ONE REPORTED MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT WAS REPORTED TO BE A (B)(6) YEAR OLD MALE WEIGHING (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10737097 ↗
• MalfunctionOct 26, 2020Retraction Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Retraction Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG80186 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON DETACHMENT, RETRACTION ISSUE, MARKER BANDS NOT IN LOCATION AND MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT IS A 53 YEAR OLD MALE WEIGHS 210 LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10737027 ↗
• MalfunctionJul 16, 2020Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG80166 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286848 ↗
• MalfunctionJul 16, 2020Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL ATG80166 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND PEELED / DELAMINATED. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE WEIGHT OF (B)(6) YEAR OLD MALE PATIENT IS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286846 ↗
• InjuryJun 4, 2020Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE COMMON FEMORAL AND ILIAC VEIN, THE PTA BALLOON ALLEGEDLY DETACHED FROM THE CATHETER SHAFT AND HAD A RETRACTION ISSUE. IT WAS FURTHER REPORTED THAT THE DETACHED SEGMENT WAS LODGED INTO THE SUBCUTANEOUS TISSUE. REPORTEDLY, THE PATIENT REQUIRED MEDICAL INTERVENTION TO CUTDOWN AND REMOVE THE DETACHED SEGMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY POST PROCEDURE.

  Patient problems: Injury

  MAUDE report 10117900 ↗
• MalfunctionApr 16, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL ATG80166 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED AN (B)(6) FEMALE PATIENT WEIGHING (B)(6) WITH NOT REPORTED CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9967985 ↗
• MalfunctionApr 15, 2019Material Frayed; Material Rupture; Material Frayed; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL ATG80166 ATLAS GOLD PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED THEN FRAYED. THE EVENT DID INVOLVE THE PATIENT BUT THERE WAS NO IMPACT OR CONSEQUENCE TO THE PATIENT. THE PATIENT WAS A 54-YEAR-OLD FEMALE WEIGHING 202 LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515195 ↗
• MalfunctionApr 15, 2019Material Frayed; Retraction Problem; Material Rupture; Material Frayed; Retraction Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL ATG80166PTA BALLOON DILATATION CATHETER EXPERIENCED MATERIAL FRAYED, A RETRACTION PROBLEM, A DETACHMENT OF DEVICE OR COMPONENT, AND A MATERIAL RUPTURE. THIS EVENT WAS REPORTED FROM A SINGLE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT WAS A 58 YEAR OLD, FEMALE AND WEIGHING 110 LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515090 ↗
• MalfunctionApr 15, 2019Deflation Problem; Retraction Problem; Deflation Problem; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THIS EVENT INDICATED THAT MODEL ATG80166 PTA BALLOON DILATATION CATHETER EXPERIENCED A DEFLATION ISSUE AND RETRACTION PROBLEM. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515088 ↗
• InjuryDec 21, 2018Retraction Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Retraction Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A VENOUS RECANALIZATION PROCEDURE IN THE ILIAC VEIN THE PTA BALLOON ALLEGEDLY DETACHED FROM THE CATHETER SHAFT DURING REMOVAL FROM THE PATIENT. THE DETACHED MATERIAL COULD NOT BE SNARED AND A STENT WAS USED TO PIN THE DETACHED MATERIAL TO THE VESSEL WALL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189338 ↗
• MalfunctionNov 15, 2016Deflation Problem; Leak/Splash; Unintended Movement; Deflation Problem; Leak/Splash; Unintended Movement

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN A TIGHT STENOSIS IN THE ILIAC/FEMORAL VEIN, THE BALLOON ALLEGEDLY WAS SHIFTING FORWARD OVER THE STENOSIS DURING BALLOON INFLATION. REPORTEDLY THE HEALTH CARE PROVIDER(HCP) HELD ON TO THE CATHETER TO PREVENT BALLOON MOVEMENT. UPON INFLATION, AN ALLEGED LEAK WAS OBSERVED AT THE PROXIMAL END OF THE PTA BALLOON. REPORTEDLY, THE HCP HAD DIFFICULTY DEFLATING THE BALLOON, BUT WAS ABLE TO FULLY DEFLATE THE BALLOON AND REMOVE IT WITHOUT INCIDENT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6104920 ↗
• InjuryOct 11, 2016Deflation Problem; Retraction Problem; Material Rupture; Deflation Problem; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE WAS PERFORMED FOR A TIGHT STENOSIS LOCATED IN THE SUPERIOR VENA CAVA, THE PROXIMAL PORTION OF THE PTA BALLOON ALLEGEDLY RUPTURED BELOW RBP AND DETACHED FROM THE CATHETER SHAFT. REPORTEDLY, THE MIDDLE AND DISTAL PORTIONS OF THE BALLOON DID NOT IMMEDIATELY DEFLATE DUE TO THE TIGHT STENOSIS. THE HEALTH CARE PROVIDER PLACED A STENT TO PIN THE DETACHED BALLOON SEGMENT TO THE SUPERIOR VENA CAVA WALL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6017294 ↗