Atlas® AT75124Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741062407), received between Sep 26, 2017 and Jun 22, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJun 22, 2026Break; Inflation Problem; Unraveled Material

  ON (B)(6) 2026, A PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO INFLATE. THEREFORE, UNRAVELING AND A PARTIAL BREAK WAS DETECTED AT LOCATION OF THE WATER LEAKING FROM THE PROXIMAL END OF THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25574545 ↗
• MalfunctionFeb 17, 2026Deflation Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY WOULD NOT DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24361587 ↗
• MalfunctionOct 23, 2025Deflation Problem; Deflation Problem

  ON (B)(6) 2025, A 74-YEAR-OLD FEMALE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE ATLAS PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY WOULDN'T DEFLATE. THE PROCEDURE WAS COMPLETED USING A NEEDLE TO POP THE BALLOON. THERE WERE NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366944 ↗
• MalfunctionAug 26, 2025Deflation Problem; Deflation Problem

  ON (B)(6) 2025, A MALE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE IN CEPHALIC VEIN USING THE ATLAS PTA BALLOON. DURING THE PROCEDURE THE BALLOON ALLEGEDLY WOULD NOT DEFLATE. IT WAS FURTHER REPORTED THAT A NEEDLE THROUGH PATIENT'S CHEST WALL WAS USED TO PUNCTURE THE BALLOON TO DEFLATE IT. REPORTEDLY, AFTER DEFLATING WITH NEEDLE PUNCTURE, THE PROCEDURE WAS ABLE TO CONTINUE WITHOUT ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892281 ↗
• MalfunctionMay 7, 2025Deflation Problem; Inflation Problem; Difficult to Remove; Deflation Problem; Inflation Problem; Difficult to Remove

  ON (B)(6) 2025, A 27-YEAR-OLD MALE PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS PTA BALLOON CATHETER. ANGIOPLASTY BALLOON FAILED TO INFLATE AND REMOVED FROM THE BODY. BALLOON INFLATED OUTSIDE THE BODY WITHOUT ISSUE. THE BALLOON REINSERTED INTO BODY INFLATED AND IT WAS FAILED TO DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974152 ↗
• MalfunctionApr 17, 2025Deflation Problem; Inflation Problem; Difficult to Remove; Deflation Problem; Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY DIFFICULT TO DEFLATE. IT WAS FURTHER REPORTED THAT IT DID DEFLATE A LITTLE AND IT WAS WITHDRAWN THROUGH THE VEIN AND THROUGH THE SHEATH WITHOUT DAMAGE. REPORTEDLY, THERE WAS DIFFICULTY IN BALLOON INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856500 ↗
• 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 21262411 ↗
• MalfunctionNov 4, 2024Deflation Problem; Material Frayed; Material Deformation; Deflation Problem; Material Frayed; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20597046 ↗
• MalfunctionFeb 20, 2024Deflation Problem; Material Frayed; Material Rupture; Improper or Incorrect Procedure or Method; Deflation Problem; Material Frayed; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY REFUSED TO DEFLATE. FURTHER IT WAS REPORTED THAT THE BALLOON WAS HYPER INFLATED UNTIL IT RUPTURED AT 30 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738833 ↗
• MalfunctionApr 1, 2022Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING A ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY FOUND TO BE RUPTURED AT 6ATM PRESSURE. IT WAS FURTHER REPORTED THAT THE DEVICE HAD REMOVAL ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13973897 ↗
• MalfunctionJan 18, 2022Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282323 ↗
• MalfunctionNov 15, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD A DEFLATION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817920 ↗
• MalfunctionOct 27, 2021Tear, Rip or Hole in Device Packaging; Material Deformation; Tear, Rip or Hole in Device Packaging; Material Deformation

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE CATHETER WAS ALLEGEDLY KINKED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12702233 ↗
• MalfunctionSep 9, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12446219 ↗
• MalfunctionAug 4, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, PTA BALLOON WAS ALLEGEDLY DIFFICULT TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12272308 ↗
• MalfunctionJun 21, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. THE BALLOON WAS PUNCTURED USING A NEEDLE AND THE CONTENTS WERE ASPIRATED AND THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 12031245 ↗
• MalfunctionJun 15, 2021Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER ALLEGEDLY STUCK IN THE SHEATH. IT WAS FURTHER REPORTED THAT CATHETER ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11997526 ↗
• MalfunctionOct 26, 2020Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THE MODEL AT75124 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION PROBLEM. THE REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT'S AGE, GENDER AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10732585 ↗
• MalfunctionOct 15, 2019Material Frayed; Inflation Problem; Peeled/Delaminated; Material Frayed; Inflation Problem; Peeled/Delaminated

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AT75124 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL FRAYED, INFLATION ISSUES, PEELED LAYER, AND UNRAVELED MATERIAL. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194970 ↗
• MalfunctionSep 14, 2018Crack; Deflation Problem; Retraction Problem; Crack; Deflation Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT SUBCLAVIAN VEIN, THE PTA BALLOON ALLEGEDLY HAD DIFFICULTY DEFLATING. IT WAS FURTHER REPORTED THAT THE BALLOON HAD ISSUES RETRACTING THROUGH THE SHEATH. NO FURTHER TREATMENT WAS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877571 ↗
• MalfunctionSep 14, 2018Material Frayed; Retraction Problem; Material Rupture; Material Frayed; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT SUBCLAVIAN VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AND SUBSEQUENTLY HAD ISSUES RETRACTING THROUGH THE SHEATH. THE BALLOON AND SHEATH 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 7877491 ↗
• MalfunctionJul 19, 2018Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED WHEN INFLATED TO 8 ATM, ON THE FIRST INFLATION ATTEMPT. ANOTHER PTA BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7705238 ↗
• MalfunctionJan 9, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A FISTULAGRAM WITH BALLOON ANGIOPLASTY OF THE RIGHT SUBCLAVIAN AND RIGHT BRACHIOCEPHALIC VEIN, THE PTA BALLOON MATERIAL ALLEGEDLY TORN UPON REMOVAL THROUGH THE SHEATH. UPON FURTHER EXAMINATION ON THE BACK TABLE, THE OUTER LAYER OF THE BALLOON WAS VISIBLY TORN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7175407 ↗
• MalfunctionNov 21, 2017Torn Material

  PT UNDERWENT FISTULOGRAM WITH BALLOON ANGIOPLASTY OF THE RIGHT SUBCLAVIAN AND RIGHT BRACHIOCEPHALIC VEIN. DURING THE PROCEDURE, THE BALLOON USED IN THE PT'S BLOOD VESSEL APPEARED TO LOOK TORN WHEN REMOVED THROUGH THE SHEATH. INTEGRITY OF BALLOON WAS CHECKED BY INFLATING THE BALLOON WHILE ON THE BACK TABLE AFTER THE TEAR WAS DISCOVERED. THE BALLOON APPEARED TO HAVE BEEN TORN ONLY IN THE OUTER LAYER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7049094 ↗
• MalfunctionSep 26, 2017Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT UPON REMOVING THE PTA BALLOON THROUGH THE 7FR SHEATH THE PEBAX WAS ALLEGEDLY PEELING OFF DURING THE FIRST INFLATION ATTEMPT. THE BALLOON AND GUIDEWIRE WERE REMOVED FROM THE PATIENT WITHOUT ISSUE. 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 6894948 ↗