Atlas® AT75164Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00801741062469), received between Aug 1, 2017 and Sep 3, 2025 — classified as 10 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (17 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Material Rupture; Material Rupture

  A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING ATLAS PTA BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON ALLEGEDLY GOT POPPED BEFORE FULL INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952008 ↗
• MalfunctionJun 23, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS RUPTURED AT 8 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22305527 ↗
• MalfunctionFeb 14, 2025Material Frayed; Peeled/Delaminated; Unraveled Material; Material Frayed; Peeled/Delaminated; Unraveled Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21382681 ↗
• MalfunctionJan 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT FEMORAL VEIN VIA VENA CAVA STENOSIS, THE PTA BALLOON ALLEGEDLY RUPTURED DURING DILATATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21135781 ↗
• MalfunctionJan 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 12 ATM WHILE INFLATING INSIDE THE CENTRAL VEIN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21122719 ↗
• InjuryNov 13, 2024Deflation Problem; Inflation Problem; Difficult to Remove; Material Twisted/Bent; Deflation Problem; Inflation Problem; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DID NOT DEFLATE. IT WAS FURTHER REPORTED THAT BALLOON HAD TO BE PUNCTURED AND A SECOND ACCESS SITE WAS MADE TO REMOVE IT. REPORTEDLY, THERE WAS DIFFICULTY IN RETRACTING THE DEVICE. FURTHERMORE, THE TIP OF THE BALLOON ALLEGEDLY TWISTED UPON INFLATION. THE CURRENT STATUS OF THE PATIENT IS STABLE.

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

  MAUDE report 20672701 ↗
• MalfunctionNov 13, 2024Deflation Problem; Peeled/Delaminated; Unraveled Material; Material Deformation; Deflation Problem; Peeled/Delaminated; Unraveled Material; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DID NOT DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20672700 ↗
• InjuryOct 8, 2024Deflation Problem; Inflation Problem; Difficult to Remove; Unraveled Material; Material Twisted/Bent; Deflation Problem; Inflation Problem; Difficult to Remove; Unraveled Material; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DID NOT DEFLATE. IT WAS FURTHER REPORTED THAT BALLOON HAD TO BE PUNCTURED AND A SECOND ACCESS SITE WAS MADE TO REMOVE IT. REPORTEDLY, THERE WAS DIFFICULTY IN RETRACTING THE DEVICE. FURTHER, THE TIP OF THE BALLOON ALLEGEDLY TWISTED UPON INFLATION. THE CURRENT STATUS OF THE PATIENT IS STABLE.

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

  MAUDE report 20393289 ↗
• MalfunctionSep 1, 2024Entrapment of Device; Unraveled Material; Entrapment of Device; Unraveled Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20115776 ↗
• MalfunctionMar 6, 2024Inflation Problem; Unraveled Material; Material Deformation; Inflation Problem; Unraveled Material; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844064 ↗
• MalfunctionDec 13, 2023Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, DEVICE ALLEGEDLY HAD A LEAK AT THE PROXIMAL PART OF THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18316413 ↗
• MalfunctionDec 8, 2023Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY LEAKED DURING INFLATION AT 14 ATM. THE PROCEDURE WAS COMPETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291354 ↗
• MalfunctionJun 5, 2023Break; Difficult to Remove; Material Rupture; Break; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FOUND TO BE BURST WHEN THE PRESSURE WAS RELEASED. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH AND THE INTRODUCER SHEATH WAS REMOVED AWAY TOGETHER. REPORTEDLY, THE BALLOON WAS REMOVED OUT OF THE PATIENT AND THOUGH THE BALLOON ENLARGED THE SKIN WOUND, THE SURGEON DID COMPRESSION OVER THE WOUND TO STOP BLEEDING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17057342 ↗
• MalfunctionApr 15, 2023Material Frayed; Inflation Problem; Peeled/Delaminated; Unraveled Material; Material Deformation; Material Frayed; Inflation Problem; Peeled/Delaminated; Unraveled Material; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA UPPER LEFT VEIN, THE PTA BALLOON ALLEGEDLY DID NOT INFLATE COMPLETELY. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY CONSTRICTED IN THE MIDDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748419 ↗
• MalfunctionJan 10, 2023Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT BRACHIOCEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AROUND 6 ATM ON THE SECOND INFLATION ATTEMPT. IT WAS FURTHER REPORTED THAT THE RUPTURED BALLOON AND CATHETER ALLEGEDLY DETACHED UPON RETRIEVAL. REPORTEDLY, THE BALLOON WAS ALLEGEDLY UNABLE TO RETRIEVE THROUGH THE INTRODUCER SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16128674 ↗
• MalfunctionApr 28, 2022Deflation Problem; Material Frayed; Inflation Problem; Peeled/Delaminated; Material Rupture; Unraveled Material; Deflation Problem; Material Frayed; Inflation Problem; Peeled/Delaminated; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY FAILED TO INFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240209 ↗
• InjuryMar 23, 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, THE PTA BALLOON ALLEGEDLY RUPTURED IN PATIENT'S CENTRAL VEINS AND CATHETER DETACHED UPON RETRIEVAL. IT WAS FURTHER REPORTED THAT THE RUPTURED BALLOON WAS UNABLE TO RETRIEVED COMPLETELY THROUGH THE INTRODUCER SHEATH. REPORTEDLY, THE PATIENT UNDERGONE OPEN SURGERY AT THE RIGHT AXILLA TO GET THE DEVICE REMOVED. THE CURRENT PATIENT STATUS IS UNKNOWN.

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

  MAUDE report 13867527 ↗
• MalfunctionNov 1, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12726853 ↗
• MalfunctionSep 29, 2021Inflation Problem; Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Inflation Problem; Difficult to Remove; Failure to Advance; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT ARM, THE BALLOON ALLEGEDLY FAILED TO MOVE OVER THE GUIDE WIRE. IT WAS FURTHER REPORTED THAT BALLOON WAS ALLEGEDLY DIFFICULT TO BE REMOVED OFF THE GUIDEWIRE, THEREFORE, THE BALLOON AND GUIDEWIRE HAD TO BE RETRIEVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548305 ↗
• InjurySep 6, 2021Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE THROUGH THE AV FISTULA, THE DEVICE WAS ALLEGEDLY DIFFICULT TO REMOVE AND WAS STUCK COMPLETELY. THE WHOLE DEVICE WAS REMOVED AND THE PATIENT WAS SUTURED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 12427123 ↗
• MalfunctionMay 24, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PACKAGING OF THE DEVICE WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11869267 ↗
• InjuryApr 16, 2021Break; Difficult to Remove; Material Rupture; Break; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING A CENTRAL VENOPLASTY PROCEDURE THROUGH THE PROMIXAL RIGHT BRACHIOCEPHALIC VEIN, THE DEVICE ALLEGEDLY RUPTURED TRANSVERSELY AND GOT STUCKED AT THE TIP OF THE SHEALTH UPON REMOVAL. PATIENT WAS SENT TO SURGICAL TEAM TO DO OPEN SURGERY FOR RETRIEVAL OF BALLOON AND REPAIRING OF CENTRAL VEINS. VENOPLASTY PROCEDURE WAS ABANDONED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 11676550 ↗
• MalfunctionApr 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING CATHETER PLACEMENT PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612450 ↗
• MalfunctionJan 19, 2021Unraveled Material; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL AT75164 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED UNRAVELED MATERIAL. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENTS¿ AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11197833 ↗
• InjuryJan 13, 2021Difficult to Remove; Material Separation; Material Deformation; Difficult to Remove; Material Separation; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR ABDOMINAL AORTIC OCCLUSION, THE DEVICE ALLEGEDLY WAS DIFFICULT TO REMOVE. IT WAS FURTHER REPORTED THAT BALLOON CATHETER WAS ALLEGEDLY DEFORMED. REPORTEDLY, THE CAPSULE MEMBRANE WAS ALLEGEDLY SEPARATED FROM THE DELIVERY SYSTEM AND DEVICE WAS REMOVED. THE PATIENT CURRENT STATUS WAS NORMAL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11162462 ↗