Atlas® AT75144Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00801741062438), received between Jan 8, 2017 and Sep 30, 2026 — classified as 1 death, 7 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (36 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 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Deflation Problem

  On (b)(6)2026, a (b)(6) male patient underwent an angioplasty procedure using the PTA balloon. During the procedure, the balloon allegedly failed to deflate following inflation. To resolve the issue, the balloon was punctured using a transseptal needle, after which it successfully deflated and was withdrawn through the sheath. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942965 ↗
• InjurySep 22, 2026Deflation Problem; Difficult to Remove

  On (b)(6) 2026, a patient underwent an angioplasty procedure using the Atlas PTA balloon. During the procedure, the balloon failed to deflate within the subclavian vein and could not be withdrawn through the sheath. To facilitate removal, the balloon was punctured and fluid was aspirated using multiple syringes until the balloon volume was sufficiently reduced. The balloon, sheath, and guidewire were then removed together. The patient experienced collateral bleeding and developed a hematoma; manual pressure was applied to achieve hemostasis. The patient was monitored for approximately 8 hours and was subsequently discharged. The procedure was successfully completed using a replacement balloon. At follow up, the patient was reported to be doing well.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50851661 ↗
• MalfunctionAug 7, 2026Deflation Problem; Difficult to Remove

  A patient underwent a percutaneous transluminal angioplasty (PTA) procedure using an Atlas balloon catheter. During the procedure, it was reported that the balloon failed to deflate within the subclavian vein. It was further reported that the HCP was unable to withdraw the balloon through the sheath. To facilitate safe removal, the balloon was cut at the tip and subsequently retrieved. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50169285 ↗
• MalfunctionJul 30, 2026Break; Material Deformation

  On (b)(6) 2026, a patient was prepped for a percutaneous transluminal angioplasty (PTA) procedure using an Atlas balloon catheter. Prior to the procedure, it was noted that the balloon catheter had become disconnected from the sheath. It was further reported that the balloon had partially detached from the device while remaining partially attached. it was broken before they used it. The procedure was subsequently completed using an alternative device. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50078385 ↗
• MalfunctionMar 30, 2026Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724977 ↗
• MalfunctionJan 13, 2026Difficult to Remove; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. REPORTEDLY, WHILE TRYING TO REMOVE THE PRODUCT, THE SHEATH HAD TO BE REMOVED AS WELL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050572 ↗
• MalfunctionNov 6, 2025Deflation Problem; Entrapment of Device; Difficult to Remove; Deflation Problem; Entrapment of Device; Difficult to Remove

  ON (B)(6) 2025, A (B)(6) MALE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS PTA BALLOON VIA LEFT UPPER ARM GRAFT TO THE ACCESS SITE OF SUPERIOR VENA CAVA, BRACHIOCEPHALIC, AND AXILLARY VEINS. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON ALLEGEDLY WOULD NOT DEFLATE AND FURTHER IT GOT STUCK IN A CENTRALLY LOCATED STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23483409 ↗
• MalfunctionOct 30, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY DID NOT DEFLATE. IT WAS FURTHER REPORTED THAT BALLOON HAD TO BE PUNCTURED WITH A NEEDLE TO RELEASE PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423492 ↗
• MalfunctionOct 22, 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 ALLEGEDLY UNABLE TO DEFLATE THE BALLOON. FURTHER, THE DEVICE HAD DIFFICULTY RETRACTING THE DEVICE THROUGH THE INTRODUCER SHEATH FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355560 ↗
• MalfunctionOct 22, 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 ALLEGEDLY UNABLE TO DEFLATE AND DIFFICULTY TO PULL BACK THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355498 ↗
• MalfunctionJan 29, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, IT WAS NOTICED THAT THE PRODUCT WAS ALLEGEDLY MISLABELED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261555 ↗
• MalfunctionDec 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED ON THE FIRST INFLATION AT MINIMAL PRESSURE 6 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032783 ↗
• MalfunctionDec 11, 2024Material Frayed; Difficult to Remove; Unraveled Material; Material Frayed; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA RIGHT INTERNAL JUGULAR, THE PTA BALLOON ALLEGEDLY BEGAN TO FRAY AFTER MULTIPLE INFLATIONS. IT WAS FURTHER REPORTED THAT FIBERS OF BALLOON APPEAR TO BE COMING OFF. REPORTEDLY, THE PTA BALLOON ALLEGEDLY HAD MILD RESISTANCE WHILE REMOVAL THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20900163 ↗
• MalfunctionNov 24, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20767865 ↗
• MalfunctionOct 28, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA FEMORAL VEIN, THE PTA BALLOON ALLEGEDLY DID NOT DEFLATE. IT WAS FURTHER REPORTED THAT THE DOCTOR HAD TO DIRECTLY STICK THE FEMORAL VEIN TO PUNCTURE AND DEFLATE THE BALLOON. REPORTEDLY, THE BALLOON WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20543036 ↗
• MalfunctionSep 10, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY WOULD NOT DEFLATE ON THIRD DEFLATION. IT WAS FURTHER REPORTED THAT THE DOCTOR HAD TO CUT CATHETER SHAFT TO REMOVE BALLOON. REPORTEDLY, THERE WAS SOME DIFFICULTY IN REMOVING FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179697 ↗
• MalfunctionSep 4, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20141252 ↗
• MalfunctionJul 9, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD A LEAK FROM THE BALLOON. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706756 ↗
• MalfunctionMay 24, 2024Deflation Problem; Difficult to Remove; Failure to Advance; Material Deformation; Deflation Problem; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT COMMON ILIAC VEIN, THE PTA BALLOON ALLEGEDLY COULD NOT PASS THROUGH THE END OF THE STENT. IT WAS FURTHER REPORTED THAT THE BALLOON WAS STILL FOUND TO BE FILLED UNDER NEGATIVE PRESSURE FOR SEVERAL MINUTES AND WAS PUNCTURED TO MAKE IT LAXATIVE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390521 ↗
• MalfunctionMay 6, 2024Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT EXTERNAL ILIAC AREA, THE DEVICE WAS ALLEGEDLY FAILED TO PUMP THE BALLOON WITH A PRESSURE PUMP AFTER THE STENT WAS IMPLANTED. IT WAS FURTHER REPORTED THAT THE PTA BALLOON WAS ALLEGEDLY UNABLE TO BE REMOVED. REPORTEDLY, AN EXTRACORPOREAL PUNCTURE NEEDLE WAS USED TO PUNCTURE THE BALLOON PERCUTANEOUSLY THROUGH THE BLOOD VESSEL UNDER DIGITAL SUBTRACTION ANGIOGRAPHY AND THE BALLOON WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247192 ↗
• MalfunctionMay 1, 2024Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA THE LEFT ARM GRAFT, THE PTA BALLOON ALLEGEDLY HAD SOME ISSUES DURING THE PULL OUT. IT WAS FURTHER REPORTED THAT IT LOOKED LIKE SOME STRIATIONS OF THE BALLOON HAD ALLEGEDLY COME OFF BUT WAS STILL ATTACHED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19227036 ↗
• MalfunctionApr 2, 2024Crack; Material Rupture; Crack; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021452 ↗
• MalfunctionApr 2, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO BE DEFLATED. REPORTEDLY, THE BALLOON WAS PULLED AS CLOSE TO THE NECK AREA AND WAS PUNCTURED WITH AN 18F NEEDLE UNDER ULTRASOUND GUIDANCE TO DEFLATE THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018090 ↗
• MalfunctionMar 28, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18999344 ↗
• MalfunctionJan 30, 2024Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BURST AT 6 ATM DURING THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18604236 ↗