Conquest® CQ7574Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00801741062995), received between Nov 16, 2016 and Sep 9, 2026 — classified as 3 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (35 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 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Deflation Problem; Entrapment of Device

  On (b)(6), 2026, a patient underwent an angioplasty procedure in left forearm using the Conquest PTA balloon. During the procedure, following balloon dilation, the device could not be withdrawn. To facilitate retrieval, the balloon was punctured with a cannula to achieve deflation, after which it was successfully removed from the patient. The procedure was completed using another balloon. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50687620 ↗
• MalfunctionSep 8, 2026Material Rupture

  On (b)(6) 2026, a patient underwent a percutaneous transluminal angioplasty procedure using a Conquest balloon catheter. During the procedure, while using a Bard Ultra High Pressure Balloon, it was observed that the inflation device repeatedly lost pressure during inflation attempts. The balloon was subsequently removed, and a simulated inflation test was performed outside the body, revealing a small tear in the balloon. Upon inflation, fluid sprayed directly from the tear, resulting in insufficient pressure. The procedure was successfully completed after the balloon was replaced with another balloon. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50663997 ↗
• MalfunctionAug 31, 2026Deflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50516918 ↗
• MalfunctionAug 13, 2026Difficult to Remove; Material Rupture

  On (b)(6) 2026, a patient underwent a percutaneous transluminal angioplasty (PTA) procedure using the Conquest Balloon Catheter. During the procedure, the balloon catheter allegedly experienced a longitudinal rupture, and there was difficulty retracting the balloon through the introducer sheath following the rupture. The procedure was completed using another device. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50231822 ↗
• MalfunctionJul 31, 2026Material Rupture

  On (b)(6), 2026, a patient underwent an angioplasty procedure using a Conquest PTA balloon for the treatment of stenosis of an autologous arteriovenous fistula in the left upper limb. During the procedure, a pinhole rupture of the balloon was noted. The procedure was subsequently completed using an alternative balloon catheter. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50094468 ↗
• MalfunctionMay 27, 2026Break; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE CONQUEST PTA BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE ALLEGEDLY KINKED. FURTHER IT WAS REPORTED THAT RESISTANCE WAS FELT AND UPON REMOVAL THE DEVICE FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296430 ↗
• MalfunctionMay 19, 2026Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25212109 ↗
• MalfunctionJan 29, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207398 ↗
• MalfunctionNov 3, 2025Material Rupture; Unraveled Material; Material Rupture; Unraveled Material

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23449835 ↗
• MalfunctionOct 28, 2025Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23400910 ↗
• MalfunctionSep 25, 2025Burst Container or Vessel; Leak/Splash; Material Rupture; Burst Container or Vessel; Leak/Splash; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE CONQUEST PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT THE CONTRAST AGENT LEAKED OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23141142 ↗
• MalfunctionSep 10, 2025Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE CONQUEST PTA BALLOON FOR THE TREATMENT OF STENOSIS. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY BURST. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH FOLLOWING THE BALLOON RUPTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012759 ↗
• MalfunctionAug 6, 2025Burst Container or Vessel; Burst Container or Vessel

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST PTA BALLOON CATHETER. DURING THE PROCEDURE THE PRESSURE REACHED 26 ATM AND WAS BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730399 ↗
• MalfunctionJul 29, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST PTA BALLOON CATHETER TO TREAT STENOSIS. DURING THE PROCEDURE, THE BALLOON WAS RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22640618 ↗
• MalfunctionJun 10, 2025Stretched; Failure to Advance; Device-Device Incompatibility; Material Deformation; Stretched; Failure to Advance; Device-Device Incompatibility; Material Deformation

  A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE CONQUEST AND DURING THE PROCEDURE IT WAS REPORTED THAT THE GUIDEWIRE ALLEGEDLY CANNOT PASS THROUGH THE HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174118 ↗
• MalfunctionMay 16, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22033074 ↗
• MalfunctionJan 13, 2025Material Rupture; Detachment of Device or Device Component; Material Deformation; Material Rupture; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 18 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21134687 ↗
• MalfunctionAug 9, 2024Deflation Problem; Inflation Problem; Material Deformation; Deflation Problem; Inflation Problem; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19947726 ↗
• MalfunctionJul 22, 2024Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BLAST AT 22 ATM. FURTHER IT WAS REPORTED THAT THE BALLOON WAS REMOVED FROM THE SHEATH AND THE BALLOON WAS ALLEGEDLY 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 19792191 ↗
• MalfunctionApr 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING PREPARATION OF AN ANGIOPLASTY PROCEDURE, WHEN THE PACKAGE WAS OPENED AND INSPECTED, THE PTA BALLOON WAS ALLEGEDLY FOUND TO BE LEAKING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102597 ↗
• MalfunctionFeb 27, 2024Leak/Splash; Difficult to Remove; Material Deformation; Leak/Splash; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ARTERIOVENOUS FISTULA REFLUX VEIN STENOSIS OF ARTIFICIAL BLOOD VESSELS, THE PTA BALLOON DILATATION CATHETER ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE REMOVAL OF THE CATHETER ALLEGEDLY CAUSED DEFORMATION OF THE CATHETER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18787305 ↗
• MalfunctionFeb 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED ANGIOPLASTY PROCEDURE, WHEN THE PTA BALLOON WAS REMOVED, A SMALL HOLE WAS ALLEGEDLY FOUND ON THE SIDE NEAR THE TIP OF THE BALLOON. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738414 ↗
• MalfunctionFeb 12, 2024Material Rupture; Unraveled Material; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING THE ANGIOPLASTY PROCEDURE, MIDDLE PART OF THE PTA BALLOON ALLEGEDLY HAD RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18683283 ↗
• MalfunctionNov 2, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CONNECTION BETWEEN THE BALLOON AND CATHETER ALLEGEDLY LEAKED AIR. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713116 ↗
• MalfunctionMay 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON HUB WAS ALLEGEDLY SNAPPED OFF UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274871 ↗