Conquest® CQ7578Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741063015), received between Oct 19, 2016 and Oct 28, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Burst Container or Vessel; Peeled/Delaminated; Material Rupture; Burst Container or Vessel; Peeled/Delaminated; 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 AT 16 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402004 ↗
• MalfunctionOct 17, 2025Deflation Problem; Deflation Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE CONQUEST BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY UNABLE TO DEFLATE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321576 ↗
• MalfunctionJul 23, 2019Material Frayed; Material Rupture; Material Frayed; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7578. PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A 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 8816768 ↗
• MalfunctionNov 14, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY RUPTURED PRIOR TO RBP. 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 8071808 ↗
• MalfunctionAug 30, 2018Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7835627 ↗
• MalfunctionAug 9, 2018Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material

  IT WAS REPORTED THAT AFTER AN ANGIOPLASTY PROCEDURE IN THE CEPHALIC VEIN, UNRAVELED MATERIAL WAS FOUND ON THE TIP OF THE BALLOON, UPON REMOVAL FROM THE PATIENT. NO FURTHER TREATMENT WAS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7770530 ↗
• MalfunctionMay 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED AT 18 ATM. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER PTA BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7505384 ↗
• MalfunctionMar 1, 2018Peeled/Delaminated; Retraction Problem; Unraveled Material; Patient-Device Incompatibility; Peeled/Delaminated; Retraction Problem; Unraveled Material; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING PTA BALLOON DILATATION CATHETER PROCEDURE, THE BALLOON WAS INFLATED TO 27 ATM IN THE OUTFLOW STENOSIS OFF AN UPPER ARM GRAFT. THE BALLOON DID NOT FULLY EFFACE THE LESION AND WAS REMOVED. DURING REMOVAL THE BALLOON ALLEGEDLY MET RESISTANCE AT THE SHEATH AND WAS RETRIEVED WITH DIFFICULTY. UPON REMOVAL, THE HEALTH CARE PROVIDER ALLEGEDLY NOTICED THE UNRAVELING OF THE BALLOON'S FIBERS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7308567 ↗
• MalfunctionJan 4, 2018Break; Peeled/Delaminated; Material Rupture; Break; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT AFTER THE FIRST INFLATION/DEFLATION ATTEMPT THE PTA BALLOON ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7164639 ↗
• MalfunctionApr 12, 2017Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED THAT FOLLOWING USE IN A AV FISTULA, THE BALLOON CATHETER WAS UNABLE TO BE RETRACTED THOUGH THE 7FR SHEATH. THE BALLOON AND SHEATH WERE REMOVED OVER THE GUIDEWIRE AS A SINGLE UNIT. ANOTHER BALLOON AND SHEATH WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6488102 ↗
• MalfunctionNov 3, 2016Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING A PTA PROCEDURE OF THE LOWER ARM, THE BALLOON ALLEGEDLY RUPTURED AT 27ATM DURING THE INITIAL INFLATION. IT WAS FURTHER ALLEGED THAT THE PTA BALLOON WAS RETRACTED WITH SOME DIFFICULTY THROUGH THE SHEATH AND 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 6077606 ↗
• MalfunctionOct 19, 2016Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  IT WAS REPORTED THAT THE PTA BALLOON CATHETER ALLEGEDLY RUPTURED AT 28 ATMS NEAR THE HUB ON THE WIRE SIDE WHILE TREATING THE AXILLARY VEIN. REPORTEDLY, THE PTA BALLOON CATHETER WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER BALLOON CATHETER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6042103 ↗