Conquest® CQ7588Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741063138), received between Feb 23, 2017 and Nov 13, 2025 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (10 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Deflation Problem; Inflation Problem; Material Deformation; Deflation Problem; Inflation Problem; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE VIA LEFT INTERNAL JUGULAR USING THE CONQUEST PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY FAILS TO DEFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542215 ↗
• MalfunctionJun 9, 2025Deflation Problem; Deflation Problem

  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 WITH THE INDEFLATOR. IT WAS FURTHER REPORTED THAT ATTACHED A SYRINGE TO GET THE BALLOON TO COME DOWN EVERY TIME WHEN USING IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22164974 ↗
• MalfunctionNov 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE INFLATION PORT OF THE PTA BALLOON WAS ALLEGEDLY PULLED DIRECTLY FROM THE BALLOON OR SHAFT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20672580 ↗
• MalfunctionSep 29, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501778 ↗
• MalfunctionAug 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE DISTAL TIP OF THE BALLOON WAS ALLEGEDLY BROKE ON REMOVAL FROM THE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320652 ↗
• MalfunctionJul 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE DISTAL TIP OF THE PTA BALLOON WAS ALLEGEDLY DETACHED FROM THE CATHETER WHICH WAS USED TO CONNECT FOR INFLATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15091210 ↗
• MalfunctionDec 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY HAD A PINHOLE RUPTURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11018669 ↗
• InjuryAug 18, 2020Deflation Problem; Material Frayed; Peeled/Delaminated; Deflation Problem; Material Frayed; Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT A PERCUTANEOUS NEEDLE STICK WAS USED TO DEFLATE THE BALLOON. THE PATIENT STATUS WAS NORMAL.

  Patient problems: Injury

  MAUDE report 10418752 ↗
• MalfunctionJul 16, 2020Material Frayed; Material Rupture; Unraveled Material; Material Frayed; Material Rupture; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED MALFUNCTION INDICATED THAT MODEL CQ7588 PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED, MATERIAL FRAYED AND UNRAVELED MATERIAL. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE MALE PATIENT IS (B)(6) YEARS OLD. WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286884 ↗
• MalfunctionJan 16, 2020Material Rupture; Material Deformation; Material Rupture; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7588 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE AND DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596787 ↗
• MalfunctionJan 16, 2020Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7588 PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED DIFFICULT TO INFLATE AND DEFLATION ISSUE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. BOTH MALFUNCTIONS INVOLVED PATIENTS WITH NO CONSEQUENCES. BOTH PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596372 ↗
• MalfunctionOct 16, 2019Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7588 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION ISSUE AND DIFFICULTY INFLATING. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198425 ↗
• MalfunctionOct 16, 2019Retraction Problem; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7588 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT WAS REPORTED AS A 65-YEAR-OLD FEMALE WEIGHING 52 KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198341 ↗
• MalfunctionJul 22, 2019Deflation Problem; Inflation Problem; Retraction Problem; Deflation Problem; Inflation Problem; Retraction Problem

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7588 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED DIFFICULT INFLATION, DEFLATION ISSUE, AND RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812016 ↗
• MalfunctionJul 19, 2019Break; Retraction Problem; Material Rupture; Break; Retraction Problem; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE EVENTS INDICATED THAT MODEL CQ7588 PTA BALLOON DILATATION CATHETER EXPERIENCED MATERIAL RUPTURE, A RETRACTION PROBLEM, AND A BREAK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED IN THE PATIENT. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808385 ↗
• MalfunctionJul 16, 2019Deflation Problem; Inflation Problem; Retraction Problem; Deflation Problem; Inflation Problem; Retraction Problem

  THIS REPORT SUMMARIZES THIRTY-NINE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQ7588 PTA BALLOON DILATATION CATHETERS WERE ALLEGEDLY DIFFICULT TO INFLATE, DEFLATE, AND RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8796171 ↗
• InjuryApr 10, 2019Burst Container or Vessel; Deflation Problem; Retraction Problem; Failure to Advance; Burst Container or Vessel; Deflation Problem; Retraction Problem; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUBCLAVIAN VEIN, THE VESSEL RUPTURED. THE VESSEL REQUIRED TREATMENT BEFORE THE PTA BALLOON COULD BE RE-INSERTED. AFTER RE-INSERTION, THE PTA BALLOON WAS ALLEGEDLY UNABLE TO DEFLATE. IT WAS FURTHER REPORTED THAT THE DEVICE BECAME STUCK INSIDE THE SHEATH AND WAS REMOVED WITH THE SHEATH AS ONE UNIT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Perforation of Vessels

  MAUDE report 8501093 ↗
• MalfunctionJan 16, 2019Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT 20 ATM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8255056 ↗
• MalfunctionNov 19, 2018Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THE PTA BALLOON ALLEGEDLY GOT STUCK INSIDE THE INTRODUCER SHEATH DURING RETRACTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8086495 ↗
• MalfunctionNov 14, 2018Material 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 Consequences Or Impact To Patient

  MAUDE report 8071799 ↗
• MalfunctionSep 24, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT UPON REMOVING THE BALLOON FROM THE PATIENT THE OUTER LAYER OF THE PTA BALLOON WAS ALLEGEDLY FOUND TO BE PEELING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7904205 ↗
• MalfunctionJun 26, 2018Break; Retraction Problem; Detachment of Device or Device Component; Break; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF AN UPPER ARM FISTULA, THE PTA BALLOON WAS ALLEGEDLY COMING APART AND COULD NOT BE REMOVED FROM THE SHEATH. 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 7640035 ↗
• MalfunctionMay 9, 2018Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material

  IT WAS REPORTED THAT POST REMOVAL OF A PTA BALLOON DILATATION CATHETER, UNRAVELED MATERIAL WAS ALLEGED FOUND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7501208 ↗
• MalfunctionMar 29, 2018Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material

  IT WAS REPORTED THAT AFTER TWO INFLATIONS (25 ATM EACH INFLATION) OF A PTA BALLOON CATHETER IN THE CEPHALIC FISTULA, UPON REMOVAL OF THE DEVICE, THE HEALTH CARE PROVIDER ALLEGEDLY IDENTIFIED UNRAVELED BALLOON FIBERS. THERE WAS NO DIFFICULTY RETRACTING THE BALLOON CATHETER THROUGH THE SHEATH, THERE WAS NO REPORTED VESSEL TRAUMA, AND THERE WERE NO STENT(S) PRESENT IN THE VESSEL TRACK OR TREATMENT SITE. REPORTEDLY, ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7382362 ↗
• MalfunctionMar 27, 2018Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material

  IT WAS REPORTED THAT DURING A PTA BALLOON DILATATION CATHETER PROCEDURE ON THE BRACHIAL ARTERY, UPON REMOVAL OF THE BALLOON CATHETER, THE HEALTH CARE PROVIDER ALLEGEDLY IDENTIFIED UNRAVELED BALLOON FIBERS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7375274 ↗