Atlas® AT75204Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741062520), received between Apr 30, 2019 and Feb 20, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Deflation Problem; Inflation Problem; Difficult to Remove; Deflation Problem; Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY COULD NOT BE FULLY INFLATED. IT WAS FURTHER REPORTED THAT THE PRESSURE BALLOON ALLEGEDLY COULD NOT BE RETRACTED, AND THE PTA BALLOON ALLEGEDLY COULD NOT BE DEPRESSURIZED. REPORTEDLY, THE PTA BALLOON WAS PUNCTURED WITH A PUNCTURE NEEDLE TO WITHDRAW THE BALLOON SYSTEM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21429255 ↗
• MalfunctionJun 21, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT LOWER EXTREMITY VEIN TO THE INFERIOR VENA CAVA, THE CONTRAST AGENT WAS ALLEGEDLY FOUND TO BE LEAKED INTO THE BLOOD VESSEL. IT WAS FURTHER REPORTED THAT AFTER THE BALLOON WAS WITHDRAWN, THE TEST IN VITRO SHOWS THAT THERE WAS ALLEGEDLY A OBVIOUS LIQUID OVERFLOW ON ONE SIDE OF THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581203 ↗
• MalfunctionJul 23, 2021Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE OUTER AND INNER PRODUCT PACKAGE WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12216292 ↗
• MalfunctionFeb 18, 2021Unraveled Material; Unraveled Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11341696 ↗
• MalfunctionFeb 11, 2021Inflation Problem; Unraveled Material; Material Deformation; Inflation Problem; Unraveled Material; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, PTA BALLOON ALLEGEDLY HAD INFLATION ISSUE. IT WAS FURTHER REPORTED THAT THE BALLOON FIBER ALLEGEDLY UNRAVELED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11312415 ↗
• MalfunctionJul 17, 2020Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT THE MODEL AT75204 PTA BALLOON DILATATION CATHETER ALLEGED UNRAVELED FIBERS. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT'S AGE, SEX AND WEIGHT WERE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10289545 ↗
• MalfunctionApr 30, 2019Material Frayed; Material Rupture; Unraveled Material; Material Frayed; Material Rupture; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THIS EVENT INDICATED THAT MODEL AT75204 PTA BALLOON DILATATION CATHETER EXPERIENCED FRAYED MATERIAL, LONGITUDINAL RUPTURE, AND UNRAVELED MATERIAL. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. THE PATIENT IS A (B)(6)-YEAR-OLD MALE. PATIENT WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8565143 ↗