Conquest® CQ75124Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00801741063251), received between Sep 27, 2016 and Sep 28, 2026 — classified as 5 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (18 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Rupture

  A patient underwent an angioplasty procedure using the Conquest PTA balloon. During the procedure, the balloon allegedly ruptured at 17 atm while being used within a stent, below its rated burst pressure of 20 atm. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914940 ↗
• MalfunctionJan 6, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23972572 ↗
• MalfunctionApr 3, 2024Material Frayed; Material Rupture; Material Frayed; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031752 ↗
• MalfunctionMar 20, 2024Leak/Splash; Unraveled Material; Leak/Splash; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT UPPER LIMB, THE PTA BALLOON ALLEGEDLY HAD AIR LEAKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18938871 ↗
• MalfunctionFeb 15, 2024Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BROKE AFTER IT LASTED TO 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 18709343 ↗
• MalfunctionDec 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT SUBCLAVIAN VEIN, THE PTA BALLOON WAS 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 18316635 ↗
• MalfunctionSep 25, 2023Material Rupture; Unraveled Material; Material Rupture; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA LEFT UPPER ARM FISTULA, THE PTA BALLOON ALLEGEDLY RUPTURED UPON INFLATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17806203 ↗
• MalfunctionDec 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059644 ↗
• MalfunctionJul 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 9 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15119314 ↗
• MalfunctionJan 24, 2022Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13331395 ↗
• MalfunctionSep 27, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT PHYSICIAN USED SYRINGE TO RUPTURE THE BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532572 ↗
• InjuryMay 11, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO DEFLATE. IT WAS FURTHER REPORTED THAT THE NEEDLE STICK WAS USED TO DEFLATE THE BALLOON. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805945 ↗
• MalfunctionFeb 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 20 RBP. 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 11371555 ↗
• InjuryJan 6, 2021Deflation Problem; Inflation Problem; Retraction Problem; Deflation Problem; Inflation Problem; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT INNOMINATE VEIN, THE PTA BALLOON ALLEGEDLY FAILED TO INFLATE. IT WAS FURTHER REPORTED THAT DISTAL PART OF THE BALLOON ALLEGEDLY FAILED TO DEFLATE AND A PERCUTANEOUS NEEDLE WAS USED TO DEFLATE THE BALLOON. REPORTEDLY, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT CURRENT STATUS WAS NORMAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11122192 ↗
• InjuryDec 1, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CENTRAL VENOUS SYSTEM, THE BALLOON ALLEGEDLY FAILED TO DEFLATE UNDER FLUOROSCOPY. IT WAS FURTHER REPORTED THAT THE SURGEON HAD TO TUG ON BALLOON TO GET IT FROM THE CENTRAL VEINS TO THE PERIPHERAL ON THE PATIENTS ARM AND USED NEEDLE TO DEFLATE. REPORTEDLY THE BALLOON DEFLATED AND WAS REMOVED WITH A SHEATH. THE PATIENT STATUS WAS NORMAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10926696 ↗
• MalfunctionOct 26, 2020Material Rupture; Unraveled Material; Material Rupture; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ75124 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED LONGITUDINAL BALLOON RUPTURE AND UNRAVELED MATERIAL. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ONE REPORTED MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT WAS REPORTED TO BE A 58 YEAR OLD MALE WHO'S WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10737518 ↗
• MalfunctionJul 15, 2020Material Frayed; Inflation Problem; Material Rupture; Material Frayed; Inflation Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ75124 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED INFLATION ISSUE, FRAYED AND LONGITUDINAL RUPTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION HAD PATIENT INVOLVEMENT BUT THE PATIENT HAD NO CONSEQUENCES. THE PATIENT WAS A 62 YEAR OLD FEMALE WEIGHING 185 LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10279442 ↗
• MalfunctionApr 20, 2020Peeled/Delaminated; Peeled/Delaminated

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ75124 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED PEELED / DELAMINATED. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9979444 ↗
• MalfunctionApr 16, 2020Break; Break

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ75124 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED BREAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID NOT INVOLVE PATIENT WITH NO PATIENT CONTACT. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9967637 ↗
• MalfunctionApr 16, 2020Difficult to Remove; Retraction Problem; Difficult to Remove; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ75124 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DIFFICULT TO REMOVE AND RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9967636 ↗
• MalfunctionApr 15, 2020Retraction Problem; Material Rupture; Retraction Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ75124 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND RETRACTION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE 35 YEAR OLD MALE PATIENT WAS 210 LB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9965454 ↗
• MalfunctionJan 15, 2020Deflation Problem; Material Rupture; Deflation Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ75124, PTA DILATATION CATHETER, ALLEGEDLY EXPERIENCED A DEFLATION ISSUE. THIS INFORMATION WAS RECIEVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9593808 ↗
• MalfunctionJan 15, 2020Failure to Fold; Retraction Problem; Failure to Fold; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ75124 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A RETRACTION PROBLEM AND FAILURE TO FOLD. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593662 ↗
• InjuryDec 30, 2019Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA JUGULAR VEIN, THE PTA BALLOON ALLEGEDLY DETACHED AND TRAVELED TO THE PULMONARY ARTERY. IT WAS REPORTED THAT THE BALLOON WAS DEFLATED AND ATTEMPTED TO BE PULLED THROUGH VENOTOMY, HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL DUE TO TIGHTNESS. THE PHYSICIAN TRIED TO INFLATED THE BALLOON ONCE AGAIN TO MAKE THE VENOTOMY BIGGER AND REMOVE THE BALLOON FROM THE PATIENT, BUT DURING THIS ATTEMPT USING A SYRINGE TO APPLY PRESSURE, THE BALLOON, PART OF THE SHAFT AND OTHER MATERIALS DETACHED AND TRAVELED TO THE PULMONARY ARTERY. THE PATIENT WAS SENT TO THE HOSPITAL WHERE INTERVENTIONAL RADIOLOGIST WAS ABLE TO RETRIEVE THE DEVICES SUCCESSFULLY WITH NO HARM TO THE PATIENT. THERE WAS NO REPORTED COMPLICATIONS TO THE PATIENT, AND WAS REPORTED TO BE MEDICALLY STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9531517 ↗
• MalfunctionOct 16, 2019Peeled/Delaminated; Material Rupture; Material Split, Cut or Torn; Peeled/Delaminated; Material Rupture; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL CQ75124 PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED, PEELED, AND EXPERIENCED MATERIAL SPLIT, CUT OR TORN. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9197782 ↗