Atlas® AT120144Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741062636), received between Mar 30, 2017 and Jan 29, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Deflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207463 ↗
• MalfunctionJun 18, 2025Packaging Problem; 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 PRODUCT WAS ALLEGEDLY BENT INSIDE THE SHIPPING BOX. IT WAS FURTHER REPORTED THAT THE PRODUCT WAS NOT DAMAGED BUT ARRIVED WITH THE OUTER AND INNER CONTAINERS DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22278734 ↗
• MalfunctionJan 23, 2025Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY LEAKED FROM TIP AT 16 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21215842 ↗
• MalfunctionSep 10, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, WHEN THE SURGEON WENT TO DEFLATE THE BALLOON, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO BE DEFLATED. IT WAS FURTHER REPORTED THAT THE SURGEON USED ANOTHER DEVICE TO POP THE BALLOON TO GET IT OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20186875 ↗
• MalfunctionJun 6, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT ARM ATRIOVENTRICULAR FISTULA, THE PTA BALLOON CATHETER ALLEGEDLY GOT STUCK WHILE REMOVING IT FROM THE SHEATH. IT WAS FURTHER REPORTED THAT AFTER SEVERAL ATTEMPTS OF REMOVAL, THE BALLOON ALLEGEDLY SEPARATED FROM THE SHAFT WHILE IN THE SHEATH. REPORTEDLY, THE DETACHED BALLOON WAS REMOVED FROM THE PATIENT COMPLETELY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17069531 ↗
• MalfunctionAug 3, 2022Material 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, THE PTA BALLOON ALLEGEDLY HAD INFLATION ISSUE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY DEFORMED. REPORTEDLY, AFTER THE DEVICE WAS REMOVED, A WIRE WAS WRAPPED AROUND THE DISTAL ASPECT OF THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15154603 ↗
• MalfunctionMar 16, 2021Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON AND SHEATH WAS REMOVED TOGETHER OVER THE WIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11493925 ↗
• MalfunctionNov 10, 2020Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY SHEARED OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10814983 ↗
• MalfunctionOct 30, 2020Material Frayed; Material Deformation; Material Frayed; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL AT120144 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED FRAYED MATERIAL AND MATERIAL DEFORMATION. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10760219 ↗
• MalfunctionApr 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL AT120144 ATLAS PTA BALLOON DILATION CATHETER HAD A DISLOCATED MARKER BAND. OF THIS EVENT, THE DEVICE WAS USED ON THE PATIENT BUT THE PATIENT WAS NOT INJURED. THE PATIENT¿S AGE, SEX, AND WEIGHT WERE NOT PROVIDED. THE AT120144 ATLAS PTA BALLOON DILATION CATHETER WAS NOT RETURNED, BUT A DHR WAS PERFORMED ON THE ASSOCIATED LOT NUMBER. RESULTS WERE INCONCLUSIVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8522902 ↗
• MalfunctionNov 19, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PREPARATION FOR PROCEDURE AN ALLEGED HAIR WAS IDENTIFIED IN THE STERILE PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8084095 ↗
• MalfunctionOct 29, 2018Material Frayed; Peeled/Delaminated; Unraveled Material; Failure to Advance; Device-Device Incompatibility; Material Frayed; Peeled/Delaminated; Unraveled Material; Failure to Advance; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY COULD NOT ADVANCE OVER THE WIRE AFTER BEING INFLATED INSIDE A STENT. IT WAS FURTHER REPORTED THAT AFTER REMOVING THE BALLOON FROM THE PATIENT, UNRAVELED MATERIAL WAS FOUND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8015993 ↗
• MalfunctionMay 4, 2018Break; Deflation Problem; Retraction Problem; Break; Deflation Problem; Retraction Problem

  IT WAS REPORTED THAT AFTER MULTIPLE INFLATIONS WITHIN THE ILIAC VEIN, THE BALLOON WAS DEFLATED AND ALLEGEDLY DIFFICULT TO RETRACT INTO THE 8 FR SHEATH. REPORTEDLY, ANOTHER INFLATION DEVICE WAS ALLEGEDLY USED TO FURTHER DEFLATE THE BALLOON AND MAINTAIN NEGATIVE PRESSURE DURING RETRACTION; HOWEVER, THE BALLOON CATHETER WOULD NOT FULLY RETRACT INTO THE SHEATH. THE BALLOON CATHETER AND SHEATH WERE REMOVED TOGETHER AS A SINGLE UNIT WHICH REQUIRED ENLARGEMENT OF THE COMMON FEMORAL VEIN ACCESS SITE. NO FURTHER TREATMENT WAS PROVIDED AND THE PROCEDURE WAS CONCLUDED. THE PATIENT WAS REPORTEDLY DOING WELL POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7488957 ↗
• MalfunctionApr 20, 2018Peeled/Delaminated; Retraction Problem; Unraveled Material; Peeled/Delaminated; Retraction Problem; Unraveled Material

  IT WAS REPORTED THAT AFTER A ANGIOPLASTY PROCEDURE IN THE LEFT ILIAC VEIN, THE PTA BALLOON FIBERS WERE FOUND TO BE ALLEGEDLY UNRAVELED AND PEELING OFF OF THE BALLOON. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY RETRACTING THE BALLOON THROUGH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7447442 ↗
• InjuryOct 25, 2017Material Frayed; Peeled/Delaminated; Retraction Problem; Material Frayed; Peeled/Delaminated; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT ILIAC VEIN, AFTER SEVERAL INFLATIONS, THE PTA BALLOON ALLEGEDLY RUPTURED AT 20 ATM AND THEN ALLEGEDLY GOT STUCK IN THE STENT THAT WAS PRESENT AT THE LESION SITE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED WITH FORCE FROM THE PATIENT. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. REPORTEDLY, THE HEALTH CARE PROVIDER USED ANOTHER STENT TO PIN THE BALLOON FRAGMENT TO THE LESION SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976608 ↗
• MalfunctionMar 30, 2017Deflation Problem; Retraction Problem; Deflation Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, AFTER SEVERAL ATTEMPTS THE PTA BALLOON ALLEGEDLY WOULD NOT DEFLATE. THE BALLOON AND SHEATH WERE REMOVED AS A SINGLE UNIT. 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 6446141 ↗