Conquest® CQ7586Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741063121), received between Feb 26, 2018 and Sep 10, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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.

• MalfunctionSep 10, 2024Deflation Problem; Material Deformation; Deflation Problem; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179021 ↗
• MalfunctionMar 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON RUPTURE ALLEGEDLY OCCURRED AT THE FIRST EXPANSION AT 12 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18872574 ↗
• MalfunctionFeb 17, 2023Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  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 16395340 ↗
• MalfunctionOct 21, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY DIFFICULT TO BE REMOVED FROM THE SHEATH AFTER DEFLATION. IT WAS FURTHER REPORTED THAT THE BALLOON AND THE SHEATH WAS REMOVED TOGETHER AS A ONE UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649129 ↗
• MalfunctionOct 27, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7586 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED FOREIGN MATERIAL. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10742663 ↗
• MalfunctionFeb 26, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A TIGHT LESION IN THE LEFT CEPHALIC ARCH, PEELED PEBAX MATERIAL WAS ALLEGEDLY FOUND ON THE PTA BALLOON UPON REMOVAL FROM THE PATIENT. THERE WERE NO REPORTED RETRACTION ISSUES. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7296982 ↗