Conquest® CQ5084Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741063060), received between Nov 28, 2016 and Mar 9, 2026 — classified as 10 malfunctions.

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

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE BY USING THE CONQUEST PTA BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543085 ↗
• MalfunctionJul 20, 2025Deflation Problem; Deflation Problem

  ON (B)(6) 2025, A 52-YEAR-OLD MALE PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST PTA BALLOON CATHETER FOR TIPS PROCEDURE. DURING THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE AND HAD TO BE REMOVED FULLY INFLATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552167 ↗
• MalfunctionJul 7, 2025Deflation Problem; Difficult to Remove; Material Deformation; Deflation Problem; Difficult to Remove; Material Deformation

  A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY WOULD NOT DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409542 ↗
• MalfunctionApr 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY COULD NOT BE INFLATED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS FOUND TO BE LEAKING. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21736239 ↗
• MalfunctionJan 11, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS PULLED BACK THROUGH THE SHEATH AND REMOVED AS SINGLE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11145213 ↗
• MalfunctionJul 16, 2020Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ5084 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED LEAK AND DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. 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 10286922 ↗
• MalfunctionApr 16, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF REPORTED INFORMATION INDICATES THAT MODEL CQ5084, PTA BALLOON DILATATION CATHETER, ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9967929 ↗
• MalfunctionApr 30, 2018Peeled/Delaminated; Retraction Problem; Material Rupture; Peeled/Delaminated; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT UPON REMOVAL OF A PTA BALLOON DILATATION CATHETER, BALLOON FIBERS WERE FOUND ALLEGEDLY PEELED. REPORTEDLY, UPON PULLING OF THE FIBERS, A SLIT WAS ALLEGEDLY DISCOVERED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7474683 ↗
• MalfunctionMar 14, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AFTER COMPLETING DILATATION AT APPROXIMATELY 10ATM OF A NORMAL DENSITY LESION, THE THIRD LAYER OF THE PTA BALLOON ALLEGEDLY WAS PEELING OFF. 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 7340298 ↗
• MalfunctionNov 28, 2016Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE BASILIC VEIN, THE PTA BALLOON CATHETER ALLEGEDLY GOT STUCK AT THE DISTAL TIP OF THE 6FR SHEATH AS IT WAS BEING RETRACTED AFTER THE SECOND INFLATION. THE PTA BALLOON AND SHEATH WERE EXCHANGED OVER THE GUIDEWIRE FOR A NEW BALLOON AND A 7FR SHEATH THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6130227 ↗