Atlas® AT75166Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741062476), received between Feb 8, 2017 and Feb 5, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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.

• MalfunctionFeb 5, 2026Deflation Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE BY USING THE ATLAS BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265534 ↗
• MalfunctionMay 5, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING AN ATLAS BALLOON, THE PHYSICIAN POST DILATED OUR STENT IN A TIGHT LESION AT 8 ATM AND A SMALL PINHOLE WAS CREATED IN THE BALLOON LOSING ATMOSPHERIC PRESSURE. FURTHER, PHYSICIAN USED ANOTHER ATLAS BALLOON ON THE SHELF TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962788 ↗
• MalfunctionJul 26, 2024Failure to Fold; Material Deformation; Failure to Fold; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE RE-WRAP TOOL IN THE PTA BALLOON ALLEGEDLY APPEARED TO BE STUCK ON THE BALLOON ITSELF. IT WAS FURTHER REPORTED THAT WHEN TRIED TO PUSH THE RE-WRAP TOOL OFF THE BALLOON, IT WAS ALLEGEDLY BENT AND WOULD NOT BUDGE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19838425 ↗
• MalfunctionJul 27, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA FEMORAL VEIN, THE BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS PUNCTURED WITH THE BACK END OF THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15110377 ↗
• MalfunctionJul 6, 2022Entrapment of Device; Unraveled Material; Entrapment of Device; Unraveled Material

  IT WAS REPORTED THAT DURING A VENOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY ENTANGLED ON AN EXISTING STENT. IT WAS FURTHER REPORTED THAT THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14924874 ↗
• MalfunctionAug 17, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING A POST DILATION ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE A SMALL NICK WAS MADE TO THE BALLOON TO DEFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329702 ↗
• MalfunctionJan 4, 2021Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING POST DILATATION OF STENT IN COMMON ILIAC VEIN, THE PTA BALLOON ALLEGEDLY HAD RETRACTION ISSUE. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11106878 ↗
• MalfunctionOct 26, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AT75166 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10736569 ↗
• MalfunctionJul 20, 2020Material Frayed; Material Rupture; Unraveled Material; Material Frayed; Material Rupture; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AT75166 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE, FRAYED FIBERS, PEELED COATING, FIBER DISTURBANCE AND UNRAVELED BALLOON. 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 10299763 ↗
• MalfunctionJul 16, 2020Unraveled Material; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AT75166 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED UNRAVELED MATERIAL. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286710 ↗
• MalfunctionApr 15, 2019Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AT75166 ALLEGEDLY RUPTURED AND HAD RETRACTION ISSUES. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED INSIDE THE PATIENT WITH NO REPORTED INJURY. THE PATIENT INVOLVED WAS AS SIXTY YEAR-OLD FEMALE, OF 115 LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8516069 ↗
• MalfunctionOct 3, 2018Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT COMMON ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10ATM ON THE THIRD INFLATION ATTEMPT. REPORTEDLY, THERE WAS MODERATE DIFFICULTY RETRACTING THE BALLOON THROUGH THE SHEATH. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7930363 ↗
• MalfunctionFeb 8, 2017Material Frayed; Material Rupture; Unraveled Material; Material Frayed; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 12ATM. THE CATHETER WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6312945 ↗