Atlas® AT120204Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741062728), received between May 17, 2017 and Mar 20, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA THE ILEAC VENOUS, THE PTA BALLOON ALLEGEDLY SNAGGED A STRUT OF A PREVIOUSLY PLACED STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940215 ↗
• MalfunctionDec 6, 2023Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY GOT CAUGHT ON A STENT AFTER MULTIPLE POST-STENT INFLATIONS. IT WAS FURTHER REPORTED THAT THE BALLOON WAS COMPLETELY OFF THE CATHETER. REPORTEDLY, THE BALLOON WAS DIFFICULT TO BE REMOVED FROM THE SHEATH. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273291 ↗
• MalfunctionNov 10, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON CATHETER WAS UNABLE TO BE REMOVED AS IT GOT ALLEGEDLY CAUGHT ON THE STENT. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ABLE TO BE ADVANCED AND INFLATED AGAIN. REPORTEDLY, THE BALLOON WAS REMOVED WITH SOME RESISTANCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110549 ↗
• InjuryOct 9, 2019Deflation Problem; Retraction Problem; Deflation Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERIOR VENA CAVA VIA JUGULAR VEIN, THE PTA BALLOON ALLEGEDLY HAD DEFLATION ISSUES WHICH ADDITIONALLY ATTRIBUTED TO RETRACTION PROBLEMS. IT WAS REPORTED A FEMORAL VEIN ACCESS WAS TAKEN AND A WIRE WAS INTRODUCED TO SNARE THE BALLOON EXTERNALLY. THE BALLOON WAS MOVED DOWN TOWARDS THE FEMORAL ACCESS. A NEEDLE WAS USED TO PUNCTURE THE BALLOON AND THEN BEING REMOVED FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE PATIENT IS MEDICALLY STABLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9172935 ↗
• MalfunctionMay 17, 2017Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE IVC THE PTA BALLOON ALLEGEDLY WOULD NOT INFLATE. THE PROCEDURE WAS CONCLUDED, AND NO FURTHER TREATMENT WAS PROVIDED. REPORTEDLY, THE PROCEDURE WAS COMPLETED THE NEXT DAY WITH A NEW BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6574300 ↗