Conquest® 40 CQF7598Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741060618), received between Oct 28, 2016 and Jun 18, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST 40 PTA BALLOON CATHETER. DURING THE PREPARATION OF PROCEDURE, BALLOON WAS BEING TAKEN OUT OF THE PACKAGE AND THE WIRE PORT WAS DETACHED. THE BALLOON WAS NOT USED; ANOTHER BALLOON WAS OPENED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282151 ↗
• MalfunctionNov 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD A HOLE AT 25 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663206 ↗
• MalfunctionOct 17, 2023Deflation Problem; Inflation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Deflation Problem; Inflation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948157 ↗
• MalfunctionJan 15, 2019Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CEPHALIC ARCH, THE PTA BALLOON ALLEGEDLY RUPTURED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8251013 ↗
• InjuryDec 11, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY HAD DIFFICULTY DEFLATING. A NEEDLE STICK WAS USED TO DEFLATE THE BALLOON THROUGH THE SKIN. THE PROCEDURE WAS COMPLETED UPON REMOVAL OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Needle Stick/Puncture; No Consequences Or Impact To Patient

  MAUDE report 8151391 ↗
• MalfunctionOct 28, 2016Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PTA BALLOON CATHETER RUPTURED AT 20 ATM DURING THE FIRST INFLATION IN A CEPHALIC VEIN STENOSIS. REPORTEDLY, THE BALLOON CATHETER WAS EXCHANGED OVER THE GUIDEWIRE WITH ANOTHER BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6064959 ↗