Atlas® AT75186Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00801741062506), received between Oct 2, 2017 and Aug 17, 2022 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (29 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2022Material Frayed; Peeled/Delaminated; Difficult to Remove; Device-Device Incompatibility; Material Frayed; Peeled/Delaminated; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER ALLEGEDLY GOT STRUCK IN THE WIRE AND WAS ALLEGEDLY UNABLE TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15239531 ↗
• MalfunctionJun 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918859 ↗
• MalfunctionOct 26, 2020Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AT75186 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED RETRACTION PROBLEM AND DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. AGE, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10736588 ↗
• MalfunctionJul 15, 2020Peeled/Delaminated; Unraveled Material; Material Deformation; Peeled/Delaminated; Unraveled Material; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AT75186 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED FIBER WRAPPED AROUND THE BALLOON AND MATERIAL DEFORMATION. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. AGE, WEIGHT, AND GENDER OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10276480 ↗
• MalfunctionJan 15, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AT75186. 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. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9592288 ↗
• MalfunctionOct 15, 2019Difficult to Remove; Retraction Problem; Unraveled Material; Difficult to Remove; Retraction Problem; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL AT75186, PTA BALLOON DILATION CATHETER, ALLEGEDLY BECAME CAUGHT IN THE STENT, WAS DIFFICULT TO REMOVE FROM THE PATIENT, AND EXPERIENCED UNRAVELED MATERIAL. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9195157 ↗
• MalfunctionJul 24, 2019Material Frayed; Material Rupture; Material Frayed; Material Rupture

  THIS REPORT SUMMARIZES TWO (2) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AT75186 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL FRAYED AND A MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTIONS INVOLVED ONE PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD FEMALE PATIENT WAS (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824117 ↗
• MalfunctionJul 19, 2019Material Frayed; Material Rupture; Material Frayed; Material Rupture

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MATERIAL ON MODEL AT75186 ATLAS PTA DILATATION CATHETERS ALLEGEDLY FRAYED AND RUPTURED. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE ALLEGED MALFUNCTIONS EACH INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. BOTH PATIENTS WERE REPORTED TO BE FEMALE, ONE PATIENT WAS REPORTED TO BE (B)(6)-YEARS-OLD AND WEIGH (B)(6)LB; THE OTHER WAS REPORTED TO BE (B)(6) -YEARS-OLD AND WEIGH (B)(6) LB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809601 ↗
• MalfunctionJul 19, 2019Material Frayed; Material Rupture; Unraveled Material; Material Frayed; Material Rupture; Unraveled Material

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AT75186 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL FRAYED, MATERIAL RUPTURE, AND UNRAVELED MATERIAL. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD FEMALE PATIENT WAS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808485 ↗
• MalfunctionApr 19, 2019Material Frayed; Material Rupture; Material Frayed; Material Rupture

  THIS REPORT SUMMARIZES ONE(1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL AT75186 PTA BALLOON DILATATION CATHETER DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE LEFT COMMON ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10ATM DURING THE THIRD INFLATION ATTEMPT. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE FEMALE PATIENT, (B)(6) YEARS OF AGE WEIGHING (B)(6) LBS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8531949 ↗
• MalfunctionApr 16, 2019Material Frayed; Material Rupture; Unraveled Material; Material Frayed; Material Rupture; Unraveled Material

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL AT75186 PTA BALLOON DILATATION CATHETER DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE RIGHT COMMON ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10ATM DURING THE FOURTH INFLATION ATTEMPT. THE BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER BALLOON THAT WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE FEMALE PATIENT, (B)(6) YEARS OF AGE AND (B)(6) LBS. THIS PATIENT HAD NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520689 ↗
• MalfunctionApr 16, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES TWO (2) MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL AT75186 DILATATION CATHETER EXPERIENCED A MATERIAL RUPTURE. THESE EVENTS WERE REPORTED FROM VARIOUS SOURCES. BOTH EVENTS INVOLVED PATIENTS WITH NO REPORTED INJURY. THE TWO (2) PATIENTS WERE BOTH REPORTED AS FEMALES (B)(6) YEARS OF AGE WHOSE WEIGHT RANGED FROM (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520633 ↗
• MalfunctionApr 16, 2019Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL AT75186 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR DEVICE COMPONENT, RETRACTION PROBLEM AND MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520626 ↗
• MalfunctionFeb 1, 2019Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE LEFT COMMON ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10ATM DURING THE SECOND INFLATION ATTEMPT. THE PTA BALLOON 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 8297921 ↗
• MalfunctionJan 28, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE LEFT EXTERNAL ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6ATM DURING THE THIRD INFLATION ATTEMPT. THE PTA BALLOON 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 8282912 ↗
• MalfunctionJan 28, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE LEFT EXTERNAL ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10ATM DURING THE SECOND INFLATION ATTEMPT. THE PTA BALLOON 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 8282911 ↗
• MalfunctionJan 27, 2019Material Frayed; Peeled/Delaminated; Material Puncture/Hole; Material Rupture; Material Frayed; Peeled/Delaminated; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE LEFT COMMON ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10ATM DURING THE THIRD INFLATION ATTEMPT. THE PTA BALLOON 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 8280351 ↗
• MalfunctionJan 3, 2019Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE RIGHT COMMON ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10ATM DURING THE THIRD INFLATION ATTEMPT. THE PTA BALLOON 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 8214353 ↗
• MalfunctionDec 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE LEFT COMMON ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10ATM DURING THE SECOND INFLATION ATTEMPT. THE PTA BALLOON 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 8189637 ↗
• MalfunctionDec 18, 2018Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT COMMON ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8ATM ON THE FIRST INFLATION ATTEMPT. REPORTEDLY, THERE WAS DIFFICULTY RETRACTING THE BALLOON THROUGH THE SHEATH AND SUBSEQUENTLY THE BALLOON AND SHEATH WERE REMOVED AS ONE UNIT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8177401 ↗
• MalfunctionDec 13, 2018Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE LEFT COMMON ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10ATM DURING THE THIRD INFLATION ATTEMPT. THE PROCEDURE WAS CONCLUDED, AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8162951 ↗
• MalfunctionDec 11, 2018Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE LEFT COMMON ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM DURING THE THIRD INFLATION ATTEMPT. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY RETRACTING THE BALLOON THROUGH THE SHEATH. THE PTA BALLOON 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 8151385 ↗
• MalfunctionDec 11, 2018Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE LEFT COMMON ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM DURING THE SECOND INFLATION ATTEMPT. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY RETRACTING THE BALLOON THROUGH THE SHEATH. THE PTA BALLOON 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 8151245 ↗
• MalfunctionOct 5, 2018Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT COMMON ILIAC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8ATM DURING THE THIRD INFLATION ATTEMPT. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY RETRACTING THE BALLOON THROUGH THE SHEATH. UPON REMOVING THE BALLOON AND SHEATH TOGETHER AS ONE UNIT, A PARTIAL SEGMENT OF THE BALLOON ALLEGEDLY DETACHED BUT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7940823 ↗
• MalfunctionAug 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY RUPTURED AFTER POST DILATING A WALL STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7799800 ↗