Atlas® AT75146Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741062445), received between Jan 26, 2017 and Dec 27, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087723 ↗
• MalfunctionAug 25, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY FAILED TO DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12364362 ↗
• MalfunctionOct 26, 2020Inflation Problem; Unraveled Material; Material Deformation; Inflation Problem; Unraveled Material; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL AT75146 PTA BALLOON DILATATION CATHETER ALLEGEDLY UNRAVELED MATERIAL, MATERIAL DEFORMATION AND INFLATION PROBLEM. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. A MALE PATIENTS' AGE AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10736520 ↗
• MalfunctionOct 15, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL AT75146 PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS DEVICE WAS USED IN A 60 YEAR OLD MALE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194968 ↗
• MalfunctionNov 29, 2018Material Frayed; Device-Device Incompatibility; Material Deformation; Material Frayed; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF THE SVC, THE GUIDEWIRE ALLEGEDLY FAILED TO LOAD THROUGH THE PTA BALLOON CATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8118552 ↗
• MalfunctionJan 26, 2017Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE BRACHIOCEPHALIC VEIN THE PTA BALLOON ALLEGEDLY WAS DIFFICULT TO RETRACT THROUGH THE 8FR SHEATH. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER (HCP) WAS ABLE RETRACT THE DEVICE; HOWEVER, THE BALLOON ALLEGEDLY HAD A TEAR THAT WAS IDENTIFIED POST RETRACTION. THE HCP UPSIZED TO A 9FR SHEATH AND USED ANOTHER BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6279315 ↗