Conquest® 40 CQF7554Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741060397), received between Nov 21, 2016 and Mar 17, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT ARM, THE PTA BALLOON ALLEGEDLY COULD NOT BE PRESSURIZED. IT WAS FURTHER REPORTED THAT UPON RETRIEVAL OF THE BALLOON WAS ALLEGEDLY FOUND TO BE LEAKING. REPORTEDLY, THE BALLOON WAS NOTED TO BE RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21615859 ↗
• MalfunctionMay 24, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE STERILITY OF THE DEVICE PACKAGING WAS FOUND TO BE COMPROMISED AS THE PACKAGING OF THE PRODUCT WAS ALLEGEDLY FOUND TO BE BENT. IT WAS FURTHER REPORTED THAT THE OUTER SHIPPING BOX WAS ALSO FOUND TO BE CRUSHED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390169 ↗
• MalfunctionMay 24, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE STERILITY OF THE DEVICE PACKAGING WAS FOUND TO BE COMPROMISED AS THE PACKAGING OF THE PRODUCT WAS ALLEGEDLY FOUND TO BE BENT. IT WAS FURTHER REPORTED THAT THE OUTER SHIPPING BOX WAS ALSO FOUND TO BE CRUSHED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390116 ↗
• MalfunctionMay 24, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON RECEIVED WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE STERILITY OF THE DEVICE PACKAGING WAS FOUND TO BE COMPROMISED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19389865 ↗
• MalfunctionMay 24, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON RECEIVED WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE STERILITY OF THE DEVICE PACKAGING WAS FOUND TO BE COMPROMISED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19389862 ↗
• MalfunctionMay 24, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON RECEIVED WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THE STERILITY OF THE DEVICE PACKAGING WAS FOUND TO BE COMPROMISED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19389860 ↗
• MalfunctionOct 26, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF7554 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738179 ↗
• MalfunctionJan 16, 2020Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE MALFUNCTION INDICATED THAT MODEL CQF7554 PTA BALLOON DILATATION CATHETER ALLEGEDLY PEELED AND EXPERIENCED MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THIS PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596527 ↗
• MalfunctionMay 22, 2017Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY RUPTURED (ATM UNKNOWN) IN THE LEFT ARM RADIAL ARTERY ANASTOMOSIS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6583520 ↗
• MalfunctionNov 21, 2016Retraction Problem; Failure to Advance; Retraction Problem; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE GUIDEWIRE, AND THE SHEATH WERE ALLEGEDLY DIFFICULT TO ADVANCE IN THE CEPHALIC ARCH STENOSIS; HOWEVER, THE HEALTH CARE PROVIDER (HCP) WAS ABLE TO REACH THE LESION. IT WAS FURTHER REPORTED THAT THE HCP THEN DECIDED NOT TO USE THIS DEVICE AND RETRACTED IT WITH ALLEGED DIFFICULTY. REPORTEDLY, ANOTHER PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6117453 ↗