Atlas® AT75126Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741062414), received between Oct 25, 2017 and Aug 30, 2024 — classified as 5 injuries, 4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS POPPED USING A NEEDLE TO REMOVE IT FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20104947 ↗
• MalfunctionAug 8, 2022Material 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 15181922 ↗
• MalfunctionJan 25, 2022Deflation Problem; Inflation Problem; Difficult to Remove; Material Deformation; Deflation Problem; Inflation Problem; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO INFLATE. IT WAS FURTHER REPORTED THAT THE DISTAL END OF THE BALLOON WAS FAILED TO EXPAND. REPORTEDLY USER TRIED TO FLAT THE BALLOON, BUT THE BALLOON WAS UNABLE TO BE DEFLATED. THE BALLOON WAS REMOVED FROM PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13340806 ↗
• MalfunctionJan 24, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD INFLATION ISSUE. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD DEFLATION ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13332552 ↗
• InjuryJan 19, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA POPLITEAL VEIN, THE PTA BALLOON ALLEGEDLY HAD DEFLATION ISSUE. IT WAS FURTHER REPORTED THAT POST REMOVAL OF THE BALLOON, THE PATIENT'S ILIAC AND FEMORAL VEIN WERE FOUND TO HAVE THROMBOTIC OCCLUSION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 13289451 ↗
• InjurySep 17, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA FEMORAL VEIN, THE PTA BALLOON WAS ALLEGEDLY FAILURE TO DEFLATE. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10546542 ↗
• InjuryMay 11, 2018Deflation Problem; Deflation Problem

  MEDICAL RECORDS RECEIVED AND REVIEWED. DURING A RECANALIZATION PROCEDURE, AFTER MULTIPLE INFLATIONS IN THE EXTERNAL ILIAC VEIN, A PTA BALLOON WAS UNABLE TO BE DEFLATED. A NEEDLE WAS INSERTED INTO THE BALLOON UNDER FLUOROSCOPY WHICH RESULTED IN GOOD DECOMPRESSION, AND THE DEVICE WAS EASILY REMOVED. TWO STENTS WERE PLACED AND ADDITIONAL VENOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. THE PATIENT WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION.

  Patient problems: Needle Stick/Puncture; No Known Impact Or Consequence To Patient

  MAUDE report 7509350 ↗
• InjuryNov 8, 2017Failure to Fold; Retraction Problem; Failure to Fold; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY FOLDED ON ITSELF AND THEN THE BALLOON MATERIAL BUNCHED AT THE DISTAL END. REPORTEDLY, THE BUNCHED BALLOON MATERIAL ALLEGEDLY GOT STUCK INSIDE THE SHEATH DURING REMOVAL. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SENT TO THE OR FOR SURGICAL REMOVAL OF THE BALLOON. PATIENT RECOVERED WITHOUT FURTHER INTERVENTION AND WAS DISCHARGED THE NEXT DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7011830 ↗
• InjuryOct 25, 2017Deflation Problem

  WHILE TRYING TO REMOVE AN ATLAS PTA BALLOON DILATION CATHETER, IT WOULD NOT DEFLATE COMPLETELY. THE PATIENT HAD TO BE TAKEN TO THE OPERATING ROOM (OR) FOR SURGICAL REMOVAL. SOME PAIN WAS NOTED IN PATIENT CHART, BUT OVERALL THE PATIENT RECOVERED WITHOUT FURTHER INTERVENTION AND WAS DISCHARGED THE NEXT DAY. OTHER BALLOONS OF THIS TYPE WERE REMOVED FROM THE SHELVES BY THE NURSE MANAGER AND THE REP WAS NOTIFIED TO COME IN. AT THIS TIME, MORE INFORMATION IS BEING COLLECTED ON SPECIFIC DEVICE DETAILS, WHETHER THE DEVICE WAS SAVED, AND WHAT COMMUNICATION HAS OCCURRED BETWEEN THE MANUFACTURER AND THE INTERVENTIONAL RADIOLOGY DEPARTMENT. PER SITE REPORTER: THE MANUFACTURER REP WAS NOTIFIED AND INSTRUCTED TO COME IN BY THE INTERVENTIONAL RADIOLOGY DEPARTMENT. IT IS UNKNOWN AT THIS TIME WHETHER OR NOT THE DEVICE WAS SAVED AND WILL BE PASSED TO THE MANUFACTURER REP.

  Patient problems: Pain

  MAUDE report 6975764 ↗