Atlas® AT120124Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741062605), received between Oct 17, 2017 and Dec 16, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER WAS ALLEGEDLY UNABLE TO DEFLATE. THERE WERE NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815236 ↗
• MalfunctionDec 12, 2025Deflation Problem; Deflation Problem

  A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY UNABLE TO DEFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786367 ↗
• MalfunctionJul 30, 2025Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS PTA BALLOON CATHETER. PRIOR TO THE PROCEDURE, THE PACKAGES WERE DAMAGED. IT WAS FURTHER REPORTED THAT THE INNER PROTECTIVE TUBING IS VISIBLY CRUSHED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662222 ↗
• MalfunctionJul 30, 2025Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS PTA BALLOON CATHETER. PRIOR TO THE PROCEDURE, THE PACKAGES WERE DAMAGED. IT WAS FURTHER REPORTED THAT THE INNER PROTECTIVE TUBING IS VISIBLY CRUSHED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662217 ↗
• MalfunctionMay 13, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BALLOON ALLEGEDLY WOULD NOT FULLY DEFLATE. THE INTRODUCER SHEATH HAD TO BE REMOVED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010499 ↗
• MalfunctionApr 28, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING ATLAS PTA BALLOON CATHETER. DURING THE PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. REPORTEDLY, PULLED THE BALLOON OUT OF AN INCISION WHICH HAD BEEN MADE FOR A SHEATH AND THERE WAS A DIFFICULTY IN RETRACTING THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917317 ↗
• MalfunctionSep 9, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD DEFLATION PROBLEM. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO POP THE BALLOON AND WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171495 ↗
• MalfunctionJul 25, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, IT WAS OBSERVED THAT THE BAG IN WHICH THE PTA BALLOON WAS KEPT LOOKED TORN WHEN IT WAS REMOVED FROM ITS FIRST PACKAGE (CARDBOARD). THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17386791 ↗
• MalfunctionSep 1, 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 FOR VENOUS THROMBOSIS IN THE LEFT LOWER EXTREMITY, THE BALLOON WAS ALLEGEDLY RUPTURED DURING DILATION. IT WAS FURTHER REPORTED THAT THE BALLOON WAS BROKEN IN THE PROCESS OF WITHDRAWAL AND THEN REMOVED WITH SHEATH AND RETRIEVAL DEVICE OF ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15334056 ↗
• MalfunctionJun 8, 2022Inflation Problem; Difficult to Remove; Material Rupture; Material Deformation; Inflation Problem; Difficult to Remove; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY COULD NOT BE INFLATED WITH CONTRAST AGENT FOR THE FIRST TIME. IT WAS FURTHER REPORTED THAT THE PROCESS OF REMOVING, THE BALLOON WAS ALLEGEDLY STUCK IN THE SHEATH AND THE BALLOON COULD NOT BE WITHDRAWN FROM THE PATIENT'S BODY. REPORTEDLY, LIQUID LEAKAGE WAS FOUND AFTER THE WITHDRAWAL, SO IT WAS KNOWN THAT THE BALLOON HAD BEEN BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14630332 ↗
• MalfunctionMay 20, 2022Deflation Problem; Entrapment of Device; Deflation Problem; Entrapment of Device

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA RIGHT GROIN ACCESS OF STENOSED VESSEL, THE BALLOON ALLEGEDLY HAD DEFLATION PROBLEM UPON THIRD ATTEMPT. IT WAS FURTHER REPORTED THAT NEEDLE WAS USED TO DEFLATE THE BALLOON. REPORTEDLY, THE BALLOON WAS ALLEGEDLY STICK TO THE VESSEL. THE PROCEDURE WAS COMPLETED USING XPERCT AND PERCUTANEOUSLY POPPING THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14460383 ↗
• MalfunctionJun 16, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY DIFFICULT TO REMOVE FROM THE SHEATH. REPORTEDLY THE BALLOON AND SHEATH WERE REMOVED AND USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12007817 ↗
• MalfunctionDec 21, 2018Break; Retraction Problem; Break; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT SUBCLAVIAN, THE PTA BALLOON ALLEGEDLY DETACHED WITHIN THE SHEATH. THE SHEATH AND DETACHED MATERIAL WERE REMOVED TOGETHER, AS ONE UNIT. NO FURTHER TREATMENT WAS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189653 ↗
• MalfunctionOct 17, 2017Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RENAL VEIN VIA FEMORAL VEIN ACCESS, THE PTA BALLOON ALLEGEDLY GOT STUCK INSIDE THE 7FR SHEATH DURING RETRACTION. REPORTEDLY THE SHEATH AND BALLOON WERE WITHDRAWN WITHOUT INCIDENT. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER USED AN 8FR SHEATH TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6955770 ↗