Conquest® 40 CQF7564Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741060441), received between Mar 1, 2017 and Oct 22, 2024 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, AFTER PASSING THROUGH THE SHEATH THE PRESSURE APPLIED FOR EXPANSION THE AIR PRESSURE PUMP IS PRESSURIZED TO ABOUT 2 ATM, THE PTA BALLOON ALLEGEDLY DID NOT EXPAND. IT WAS FURTHER REPORTED THAT THERE ARE AIR BUBBLES IN THE SHEATH CATHETER AND THE PRESSURE DOES NOT HIT CONSIDERED AS BALLOON LEAKAGE. REPORTEDLY, A HOLE WAS ALLEGEDLY FOUND. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20503765 ↗
• InjurySep 20, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 32 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY HAD DIFFICULTY IN RETRACTING THROUGH THE INTRODUCER SHEATH. REPORTEDLY, THE PATIENT ALLEGEDLY EXPERIENCED VESSEL INJURY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Perforation of Vessels

  MAUDE report 20267382 ↗
• MalfunctionSep 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED PERCUTANEOUS ENDOVASCULAR ANGIOPLASTY PROCEDURE IN THE ARTIFICIAL ARTERIOVENOUS FISTULA STENOSIS OF RIGHT UPPER LIMB, THE PTA BALLOON ALLEGEDLY RUPTURED AT 32 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20115718 ↗
• MalfunctionMay 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED ANGIOPLASTY PROCEDURE IN THE LEFT FOREARM ARTERIOVENOUS FISTULA STENOSIS, DURING THE SECOND EXPANSION WHEN THE PRESSURE WAS ABOUT 28 ATM, THE PTA BALLOON ALLEGEDLY BEGAN TO LEAK AND WAS CONSIDERED TO BE RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19379436 ↗
• MalfunctionSep 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BURST. IT WAS FURTHER REPORTED THAT THE BALLOON FRACTURED IN THE CENTER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17697567 ↗
• MalfunctionNov 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA LEFT ELLIPSYS ENDOVASCULAR FISTULA TOWARDS THE ARTERIAL SIDE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 15 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15812000 ↗
• MalfunctionJan 6, 2022Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 35 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173963 ↗
• MalfunctionSep 23, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12517514 ↗
• MalfunctionAug 25, 2021Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Packaging Problem; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE PACKAGED ARRIVED DAMAGED AND THE CATHETER WAS NOTED TO BE DAMAGED AS WELL. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363947 ↗
• MalfunctionMay 31, 2021Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 15 ATM. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11906724 ↗
• MalfunctionApr 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 28 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11730550 ↗
• MalfunctionOct 26, 2020Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF7564 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION ISSUE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. AGE, SEX AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738164 ↗
• MalfunctionJan 16, 2020Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF7564 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION ISSUE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. EACH MALFUNCTIONS INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. ONE PATIENT WAS A (B)(6) YEAR-OLD FEMALE WEIGHING (B)(6) LB AND THE OTHER PATIENT WAS A (B)(6) YEAR-OLD FEMALE WEIGHING (B)(6) LB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596525 ↗
• MalfunctionJul 23, 2019Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF7564 PTA BALLOON DILATATION CATHETER ALLEGEDLY HAD A DEFLATION ISSUE. THERE WAS NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE PATIENT WAS A (B)(6) YEAR-OLD FEMALE WHO WEIGHED (B)(6) POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8817172 ↗
• MalfunctionJan 7, 2019Deflation Problem; Material Rupture; Deflation Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ARTERIAL ANASTOMOSIS, THE PTA BALLOON WAS ALLEGEDLY DIFFICULT TO DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8224441 ↗
• MalfunctionAug 6, 2018Peeled/Delaminated; Material Rupture; Unraveled Material; Peeled/Delaminated; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON ALLEGEDLY RUPTURED AFTER BEING REMOVED FROM THE PATIENT. ANOTHER PTA BALLOON WAS USED TO COMPLETE THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7754860 ↗
• MalfunctionJan 5, 2018Deflation Problem; Retraction Problem; Deflation Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY IN THE JUZTA-ANASTAMOSIS THE PTA BALLOON CATHETER ALLEGEDLY WAS DIFFICULT TO DEFLATE. THERE WERE NO REPORTED RETRACTION DIFFICULTIES THROUGH THE INTRODUCER SHEATH. REPORTEDLY, THE PROCEDURE WAS CONCLUDED UPON REMOVAL OF THE BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7170223 ↗
• MalfunctionJan 5, 2018Deflation Problem; Retraction Problem; Deflation Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY IN BASILIC VEIN THE PTA BALLOON CATHETER ALLEGEDLY WAS DIFFICULT TO DEFLATE AND SUBSEQUENTLY HAD DIFFICULTIES RETRACTING THE BALLOON THROUGH THE SHEATH. REPORTEDLY, THE PROCEDURE WAS CONCLUDED UPON REMOVAL OF THE BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7168517 ↗
• MalfunctionNov 17, 2017Deflation Problem; Retraction Problem; Deflation Problem; Retraction Problem

  IT WAS REPORTED THAT THE PTA BALLOON CATHETER ALLEGEDLY WAS DIFFICULT TO DEFLATE AND SUBSEQUENT RETRACTION ISSUES THROUGH THE SHEATH WERE ENCOUNTERED. REPORTEDLY, THE PROCEDURE WAS CONCLUDED UPON REMOVAL OF THE BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7041290 ↗
• MalfunctionOct 5, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A LEFT UPPER ARM FISTULA, THE HEALTH CARE PROVIDER ALLEGEDLY HAD DIFFICULTIES DEFLATING THE PTA BALLOON. REPORTEDLY, THE ORIGINAL PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE AND SUBSEQUENTLY WAS SUCCESSFULLY REMOVED THROUGH THE SHEATH AT THE CONCLUSION OF THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6915306 ↗
• MalfunctionOct 3, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN A LEFT UPPER ARM GRAFT AT THE ARTERIAL ANASTOMOSIS, THE HEALTH CARE PROVIDER ALLEGEDLY HAD DIFFICULTIES DEFLATING THE PTA BALLOON. REPORTEDLY, THE ORIGINAL PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE AND SUBSEQUENTLY WAS SUCCESSFULLY REMOVED THROUGH THE SHEATH AT THE CONCLUSION OF THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6909644 ↗
• MalfunctionMay 8, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PTA BALLOON CATHETER WAS ALLEGEDLY SLOW TO DEFLATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6552940 ↗
• MalfunctionMay 3, 2017Deflation Problem; Material Rupture; Deflation Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT ARTERIAL ANASTOMOSIS OF THE RIGHT ARM, THE HEALTH CARE PROVIDER ALLEGEDLY HAD DIFFICULTIES DEFLATING THE PTA BALLOON. REPORTEDLY, THE ORIGINAL PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE VESSEL WAS REPORTED TO BE PATENT WITH GOOD BLOOD FLOW AT THE CONCLUSION OF THE ANGIOPLASTY PROCEDURE. HEMOSTASIS WAS OBTAINED USING A PURSE STRING SUTURE AT THE ACCESS SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6542776 ↗
• MalfunctionMar 1, 2017Material Frayed; Retraction Problem; Material Rupture; Material Frayed; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE AT THE ARTERIAL ANASTOMOSIS, THE PTA BALLOON ALLEGEDLY RUPTURED AFTER THE SECOND INFLATION ATTEMPT USING A ONE CC SYRINGE. REPORTEDLY THE BALLOON GOT STUCK IN THE SHEATH DURING RETRACTION. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL BALLOON BECAUSE THE RUPTURE OCCURRED AFTER THE STENOSIS WAS EFFACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370523 ↗