Conquest® CQ5074Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741062957), received between Apr 17, 2018 and Sep 28, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (25 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Rupture

  On (b)(6) 2026, a patient underwent a percutaneous transluminal angioplasty (PTA) procedure using a Conquest balloon catheter. During the procedure, the balloon was initially inflated to 16 atm and then deflated. It was subsequently advanced over the guidewire to the next lesion site. As the pressure was gradually increased to 25 atm, further inflation became impossible. The balloon was then deflated and retrieved, at which time a rupture was observed. The procedure was successfully completed using another balloon. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913801 ↗
• MalfunctionApr 29, 2026Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST BALLOON CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25025885 ↗
• MalfunctionDec 24, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE FOR VASCULAR STENOSIS USING THE CONQUEST BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER ALLEGEDLY RUPTURED. AS A RESULT, THE SURGERY WAS INTERRUPTED WITH DELAYED TREATMENT AND ALSO POSED RISKS OF COMPLICATIONS SUCH AS VASCULAR EMBOLISM AND INTIMAL TEAR DUE TO RESIDUAL BALLOON DEBRIS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body Embolism; No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 23887303 ↗
• MalfunctionMar 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY LEAKED AND COULD NOT BE PRESSURIZED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729652 ↗
• MalfunctionJan 24, 2025Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON WAS ALLEGEDLY BROKEN AND LEAKING FLUID. IT WAS FURTHER REPORTED THAT THE RUPTURED POSITION IS WHERE THE BALLOON AND THE CATHETER ARE CONNECTED. REPORTEDLY, WHEN FILLED, SALINE LEAKED OUT AND THE FRONT END OF THE BALLOON DID NOT RUPTURE SIGNIFICANTLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21227077 ↗
• MalfunctionAug 13, 2024Material Rupture; Unraveled Material; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE AXILLARY VEIN STENOSIS OF LEFT UPPER LIMB, AFTER ABOUT FIFTEEN SECONDS OF EXPANSION, THE PTA BALLOON ALLEGEDLY RUPTURED AND LEAKED BLOOD. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978543 ↗
• MalfunctionMar 25, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF THE ARTIFICIAL BLOOD VESSEL IN THE LEFT FOREARM, THE PTA BALLOON ALLEGEDLY COULD NOT BE RETRACTED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966919 ↗
• MalfunctionFeb 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED WHEN THE AIR PRESSURE PUMP IS PRESSURIZED TO ABOUT 18. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738589 ↗
• MalfunctionDec 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN AXILLARY VEIN, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AFTER TWELVE SECOND OF EXPANSION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298421 ↗
• MalfunctionDec 10, 2023Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AFTER TWENTY SECONDS OF EXPANSION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298420 ↗
• MalfunctionOct 31, 2023Peeled/Delaminated; Material Rupture; Unraveled Material; Peeled/Delaminated; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON CATHETER TIP WAS ALLEGEDLY RUPTURED AT 20 ATM. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED FROM THE SHEATH. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18036950 ↗
• MalfunctionJun 26, 2023Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BURST WHEN THE PRESSURE WAS LESS THAN 30 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17198913 ↗
• MalfunctionAug 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA FOREARM ARTERIOVENOUS FISTULA, THE PTA BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264274 ↗
• MalfunctionAug 8, 2022Leak/Splash; Material Rupture; Leak/Splash; 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 15184078 ↗
• MalfunctionJul 7, 2022Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 20 ATM. IT WAS FURTHER REPORTED THAT, THE BALLOON ALLEGEDLY DIFFICULT TO REMOVE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14942566 ↗
• MalfunctionJan 5, 2022Material 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 13173600 ↗
• MalfunctionSep 7, 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 12431421 ↗
• MalfunctionSep 7, 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 12431231 ↗
• MalfunctionJul 8, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134541 ↗
• MalfunctionApr 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BALLOON ALLEGEDLY BURST IN THE PROCESS OF INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670261 ↗
• MalfunctionFeb 12, 2021Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED AT 16 ATM. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY EXPERIENCED DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11320166 ↗
• MalfunctionJan 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT HAND'S INTERNAL FISTULA, THE PTA BALLOON ALLEGEDLY RUPTURED AT 18 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11221992 ↗
• MalfunctionApr 16, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ5074 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS REPORTEDLY A (B)(6) YEAR OLD MALE WEIGHING (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9967779 ↗
• MalfunctionJan 15, 2020Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ5074 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED PEELING AND UNRAVELED MATERIAL. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593572 ↗
• MalfunctionDec 4, 2018Leak/Splash; Peeled/Delaminated; Material Rupture; Leak/Splash; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY LEAKED AIR AT 23ATM. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8130104 ↗