Atlas® AT120164Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741062667), received between Oct 9, 2017 and May 12, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2025Deflation Problem; Material Deformation; Deflation Problem; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE ATLAS PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY SLOW TO DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON INFLATION PORTION OF THE CATHETER MAY HAVE BEEN BENT, AND A SMALL BLUNT NEEDLE WAS INSERTED INTO THE BALLOON INFLATION PORT TO STRAIGHTEN IT, AND THE BALLOON BEGAN TO DEFLATE SLIGHTLY FASTER. REPORTEDLY, A SECOND BALLOON WAS PLACED ALONGSIDE THE BALLOON TO APPLY EXTERNAL PRESSURE, AND THE BALLOON WAS DEFLATED AND WAS ABLE TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002473 ↗
• MalfunctionDec 26, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE MEASURES LABELED ON THE BOX ALLEGEDLY DID NOT CORRESPOND TO THE MEASURES OF THE PRODUCT INSIDE THE BOX. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021280 ↗
• MalfunctionSep 18, 2024Device Contamination with Chemical or Other Material; Material Deformation; Device Contamination with Chemical or Other Material; Material Deformation

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, WHEN THE CATHETER WAS FLUSHED WITH SALINE, THERE WAS A CREASE ALLEGEDLY FOUND IN THE BALLOON DELIVERY ROD PORTION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20243877 ↗
• MalfunctionMay 13, 2024Entrapment of Device; Unraveled Material; Entrapment of Device; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE FIBERS OF THE PTA BALLOON ALLEGEDLY GOT HOOKED TO THE STENT AND GOT LOOSE AND ENTANGLED IN THE BALLOON ITSELF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296605 ↗
• MalfunctionApr 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED WHILE BALLOONING A VEIN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19039356 ↗
• MalfunctionApr 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED WHILE BALLOONING A VEIN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19039355 ↗
• MalfunctionDec 29, 2023Material Frayed; Peeled/Delaminated; Difficult to Remove; Unraveled Material; Material Frayed; Peeled/Delaminated; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD SOME RESISTANCE UPON REMOVAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18416988 ↗
• MalfunctionOct 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY CAME OF THE SHAFT WHILE INSIDE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919633 ↗
• MalfunctionJun 30, 2021Crack; Deflation Problem; Crack; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY UNABLE TO DEFLATE FULLY AFTER INFLATION. IT WAS FURTHER REPORTED THAT DEVICE ALLEGEDLY HAD A CRACK ON THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093130 ↗
• MalfunctionOct 30, 2020Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AT120164 PTA BALLOON DIALATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND PEELED MATERIAL. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10763670 ↗
• MalfunctionApr 16, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AT120164 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968561 ↗
• MalfunctionApr 15, 2019Break; Retraction Problem; Material Rupture; Break; Retraction Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL AT120164 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A RUPTURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT, AGE, WEIGHT AND GENDER WERE NOT PROVIDED. THIS PATIENT HAD NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8516073 ↗
• MalfunctionOct 9, 2017Material Frayed; Retraction Problem; Material Rupture; Material Frayed; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 25 ATM. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER REMOVED THE BALLOON THROUGH THE SHEATH BY USING FORCE. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THE VESSEL WAS PATENT WITH GOOD BLOOD FLOW AT THE CONCLUSION OF THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6933133 ↗