Conquest® CQ7594Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00801741063190), received between Dec 12, 2016 and Apr 18, 2026 — classified as 1 injury, 33 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (19 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2026Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST BALLOON CATHETER. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER ALLEGEDLY DETACHED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919322 ↗
• MalfunctionJul 2, 2024Entrapment of Device; Material Rupture; Entrapment of Device; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT IT CAUGHT ON STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653605 ↗
• MalfunctionJan 11, 2024Difficult to Flush; Material Rupture; Difficult to Flush; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO BE FLUSHED. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490666 ↗
• MalfunctionSep 12, 2022Burst Container or Vessel; Deflation Problem; Difficult to Remove; Unraveled Material; Burst Container or Vessel; Deflation Problem; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED 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 15400475 ↗
• MalfunctionSep 12, 2022Deflation Problem; Unraveled Material; Deflation Problem; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD DEFLATION ISSUE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS PERCUTANEOUSLY POPPED WITH THE NEEDLE AND REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15400303 ↗
• MalfunctionMar 21, 2022Deflation Problem; Inflation Problem; Difficult to Remove; Deflation Problem; Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO INFLATE AND FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ABLE TO BE PULLED BACK INTO THE SHEATH AND REMOVED THE BALLOON AND SHEATH TOGETHER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13838360 ↗
• MalfunctionFeb 22, 2022Deflation Problem; Deflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576931 ↗
• MalfunctionNov 30, 2021Deflation Problem; Inflation Problem; Peeled/Delaminated; Deflation Problem; Inflation Problem; Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY INFLATING SLOWLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12891256 ↗
• MalfunctionMay 3, 2021Deflation Problem; Deflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11759029 ↗
• MalfunctionApr 27, 2021Deflation Problem; Inflation Problem; Material Rupture; Detachment of Device or Device Component; Deflation Problem; Inflation Problem; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AND DETACHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11730255 ↗
• MalfunctionApr 23, 2021Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THROUGH THE LEFT ARM, THE BALLOON WAS ALLEGEDLY UNABLE TO INFLATE AFTER SEVERAL ATTEMPTS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11714693 ↗
• MalfunctionApr 13, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PROXIMAL FIBER MATERIAL OF THE BALLOON WAS ALLEGEDLY MISALIGNED AFTER INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11654398 ↗
• MalfunctionJan 19, 2021Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7594 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED FAILURE TO INFLATE AND DEFLATION ISSUE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE FEMALE PATIENT IS (B)(6) YEARS OLD AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11197822 ↗
• InjuryJan 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PTA PROCEDURE THROUGH THE LEFT UPPER ARM AV FISTULA, THE DEVICE ALLEGEDLY RUPTURED AT LOW PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Injury

  MAUDE report 11106079 ↗
• MalfunctionOct 30, 2020Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THE MODEL CQ7594 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED FAILURE TO ADVANCE AND MATERIAL RUPTURE. THE REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT'S AGE, GENDER AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10760357 ↗
• MalfunctionOct 30, 2020Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7594 PTA BALLOON DILATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE AND LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT IS A (B)(6) YEAR OLD MALE WEIGHS (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10760340 ↗
• MalfunctionOct 27, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7594 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ONE REPORTED MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE AGE, SEX AND WEIGHT OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10742681 ↗
• MalfunctionJul 16, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7594 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286527 ↗
• MalfunctionJul 15, 2020Retraction Problem; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7594J PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED RETRACTION PROBLEM. 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 10279306 ↗
• MalfunctionJan 16, 2020Material Frayed; Inflation Problem; Material Rupture; Material Deformation; Material Frayed; Inflation Problem; Material Rupture; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7594 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED INFLATION PROBLEM, MATERIAL FRAYED, MATERIAL DEFORMATION, AND UNRAVELED MATERIAL. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE MALFUNCTION, ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCE OR IMPACT. PATIENT AGE, WEIGHT, AND GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596462 ↗
• MalfunctionJan 16, 2020Deflation Problem; Retraction Problem; Deflation Problem; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7594.PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION ISSUE, AND RETRACTION PROBLEM. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION 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 9596447 ↗
• MalfunctionJul 19, 2019Material Frayed; Material Rupture; Unraveled Material; Material Frayed; Material Rupture; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT AN CQ7594 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A MATERIAL RUPTURE, MATERIAL FRAYED, AND UNRAVELED MATERIAL. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MATERIAL RUPTURE INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCE. THE AGE, WEIGHT, AND SEX WERE NOT REPORTED FOR THE PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809666 ↗
• MalfunctionApr 15, 2019Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE EVENT INDICATED THAT MODEL CQ7594 PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED PRIOR TO REACHING 26ATM. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE ALLEGED MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515478 ↗
• MalfunctionApr 15, 2019Material Frayed; Peeled/Delaminated; Material Deformation; Material Frayed; Peeled/Delaminated; Material Deformation

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL CQ7594 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL FRAYED, PEELED LAYER, AND MATERIAL DEFORMATION. 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 8515267 ↗
• MalfunctionApr 12, 2019Deflation Problem; Retraction Problem; Material Rupture; Deflation Problem; Retraction Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL CQ7594 ALLEGEDLY HAD DEFLATION ISSUES, RETRACTION ISSUES, AND MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED INSIDE THE FIFTY-SEVEN YEAR-OLD MALE PATIENT, OF 78 KGS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511917 ↗