Conquest® CQ7554Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741062834), received between May 10, 2017 and May 31, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2022Deflation Problem; Material Frayed; Peeled/Delaminated; Unraveled Material; Detachment of Device or Device Component; Deflation Problem; Material Frayed; Peeled/Delaminated; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE DEVICE ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE PHYSICIAN ASSISTED WITH GUIDING TO REMOVE IT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14546144 ↗
• MalfunctionOct 10, 2021Material Frayed; Unraveled Material; Material Frayed; Unraveled Material

  IT WAS REPORTED THAT POST ANGIOPLASTY PROCEDURE, UNRAVELED MATERIAL WAS FOUND ON THE PTA BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12602646 ↗
• MalfunctionOct 27, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7554 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10742775 ↗
• MalfunctionNov 20, 2018Leak/Splash; Peeled/Delaminated; Leak/Splash; Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A FOREARM FISTULA, CONTRAST WAS ALLEGEDLY LEAKING AT THE DISTAL END OF THE PTA BALLOON UPON INFLATION. REPORTEDLY, ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8091044 ↗
• MalfunctionJun 25, 2018Burst Container or Vessel; Retraction Problem; Material Rupture; Detachment of Device or Device Component; Burst Container or Vessel; Retraction Problem; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY IN AN UPPER ARM DIALYSIS FISTULA, THE PTA BALLOON ALLEGEDLY RUPTURED AND WAS DIFFICULT TO RETRACT THROUGH THE SHEATH, WHICH LED TO A BALLOON DETACHMENT. THE PTA BALLOON AND SHEATH WERE REMOVED TOGETHER AS ONE UNIT. ANOTHER PTA BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7636304 ↗
• MalfunctionMay 24, 2018Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT THE DISTAL PORTION OF THE LESION AFTER A FEW INFLATION/DEFLATION ATTEMPTS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7543251 ↗
• MalfunctionMay 17, 2018Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE BALLOON FIBERS ALLEGEDLY UNRAVELED UPON REMOVING FROM THE PATIENT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7523937 ↗
• MalfunctionAug 31, 2017Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED PRIOR TO REACHING 30ATM. REPORTEDLY, THE HEALTH CARE PROVIDER ALLEGEDLY HAD DIFFICULTY REMOVING THE PTA BALLOON THROUGH SHEATH. 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 6834962 ↗
• MalfunctionMay 10, 2017Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING THE VASCULAR ACCESS INTERVENTIONAL THERAPY (VAIVT), FRAYED OUTER MATERIAL OF THE PTA BALLOON WAS ALLEGEDLY FOUND WHEN IT WAS REMOVED FROM THE PATIENT VIA A SHEATH. REPORTEDLY, BEFORE THE REMOVAL, THE CATHETER WAS INFLATED TO A PRESSURE OF 14 ATM ONCE IN THE LESION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6559402 ↗