Conquest® CQ7584Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00801741063114), received between Oct 5, 2016 and May 25, 2026 — classified as 1 death, 4 injuries, 96 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (32 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 25 most recent of 101 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2026Break; Difficult to Open or Remove Packaging Material; Material Split, Cut or Torn

  A patient was prepared for a percutaneous transluminal angioplasty (PTA) procedure using a Conquest Balloon Catheter. Prior to the procedure, upon removal of the device from its packaging, a split was observed in the catheter, rendering the device unusable. A replacement balloon catheter was used to complete the procedure. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25270345 ↗
• MalfunctionMay 8, 2026Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE IN FISTULA VEIN USING THE CONQUEST PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25121606 ↗
• MalfunctionFeb 27, 2026Break; Deflation Problem

  A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PTA PROCEDURE BY USING THE CONQUEST BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY UNABLE TO DEFLATE THE BALLOON. REPORTEDLY, WHILE REMOVING THE BALLOON THE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466593 ↗
• MalfunctionDec 29, 2025Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE CONQUEST BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED AT 20 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904101 ↗
• MalfunctionSep 2, 2025Difficult to Remove; Difficult to Remove

  ON (B)(6) 2025, A PATIENT RECEIVED PTA BALLOON ANGIOPLASTY WITH THE CONQUEST BALLOON. FOLLOWING THE USE OF THE PTA BALLOON IN THE PROCEDURE, AFTER THE AIR PRESSURE WAS FULLY RELEASED AND THE BALLOON WAS REMOVED FROM THE VASCULAR SHEATH, IT BECAME LODGED WITHIN THE VASCULAR SHEATH AND COULD NOT BE EXTRACTED. IT WAS REMOVED ALONG WITH THE VASCULAR SHEATH. THERE WERE NO REPORTED INJURIES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931614 ↗
• MalfunctionJul 29, 2025Deflation Problem; Entrapment of Device; Difficult to Remove; Deflation Problem; Entrapment of Device; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY FAILED TO DEFLATE WHICH WOULD NO LONGER FIT INTO THE INTRODUCER AND THEREFORE REMAINED STUCK IN THE PATIENT. THE INTRODUCER AND BALLOON REMOVED AT THE SAME TIME. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641974 ↗
• MalfunctionJun 18, 2025Difficult to Insert; Difficult to Remove; Device-Device Incompatibility; Difficult to Insert; Difficult to Remove; Device-Device Incompatibility

  A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST PTA BALLOON CATHETER. DURING THE PROCEDURE, THE DEVICE WAS DEPLOYED AND UNABLE TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22269951 ↗
• MalfunctionJun 16, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY WOULD NOT DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON GOT STUCK INFLATED OVER A SUPER STIFF AMPLATZ THRU A SHEATH. REPORTEDLY, THE BALLOON WAS POKED THRU A NEEDLE TO DEFLATE AND TAKE IT OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22209715 ↗
• MalfunctionMay 8, 2025Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE CONQUEST. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY CIRCUMFERENTIAL RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21982361 ↗
• MalfunctionMay 5, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY DAMAGED WHEN THE AIR PRESSURE WAS INCREASED TO 25 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959049 ↗
• MalfunctionDec 30, 2024Material Frayed; Material Rupture; Material Deformation; Material Frayed; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21033349 ↗
• MalfunctionNov 20, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT UPPER EXTREMITY OF NEW ENDOVASCULAR FISTULA, THE PTA BALLOON ALLEGEDLY HAD AN AIR LEAK. IT WAS FURTHER REPORTED THAT THE PTA BALLOON AIR PRESSURE NOT UP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20732622 ↗
• MalfunctionAug 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, A TINY BLACK RING POSSIBLY MADE OF PLASTIC WAS ALLEGEDLY FOUND LOOSE IN THE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19933568 ↗
• MalfunctionApr 8, 2024Material Frayed; Peeled/Delaminated; Material Rupture; Unraveled Material; Material Frayed; Peeled/Delaminated; Material Rupture; Unraveled Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057468 ↗
• MalfunctionMar 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE TUBE WAS ALLEGEDLY LOST FROM THE CONNECTOR. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY BROKE FROM THE TUBE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18996790 ↗
• MalfunctionNov 2, 2023Material Rupture; Unraveled Material; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR UPPER ARM TREATMENT, THE PTA BALLOON ALLEGEDLY BURST AT 12 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18054497 ↗
• MalfunctionMay 12, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY COULD NOT DEFLATE FULLY. IT WAS FURTHER REPORTED THAT IT WAS DIFFICULT TO REMOVE THE DEVICE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16917388 ↗
• MalfunctionDec 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, ATTACHMENT FOR LUER LOCK SYRINGE ON BALLOON PORT ALLEGEDLY DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15967389 ↗
• MalfunctionOct 12, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT BALLOON ALLEGEDLY DIFFICULT TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15586193 ↗
• MalfunctionMay 18, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY WOULD NOT RETRACT BACK INTO THE SHAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427951 ↗
• MalfunctionApr 13, 2022Break; Deflation Problem; Difficult to Remove; Break; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED TOGETHER WITH SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102798 ↗
• MalfunctionMar 7, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT ARM TO TREAT CENTRAL VENOUS STENOSIS, THE PHYSICIAN ALLEGEDLY FELT RESISTANCE WHILE INFLATING THE BALLOON WITH INFLATOR. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY FAILED TO DEFLATE. HOWEVER, THE SURGEON RETRACTED THE BALLOON INSIDE THE SHEATH AND REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13684871 ↗
• MalfunctionJan 18, 2022Deflation Problem; Deflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282121 ↗
• MalfunctionDec 21, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS INFLATED WITH PRESSURIZATION BUT WAS ALLEGEDLY UNABLE TO BE DEFLATED WHEN THE PRESSURE WAS REMOVED. THE BALLOON WAS EVENTUALLY WITHDRAWN AFTER BEING PIERCED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13050237 ↗
• MalfunctionDec 7, 2021Inflation Problem; Material Split, Cut or Torn; Inflation Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO INFLATE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12948158 ↗