Conquest® 40 CQF7584Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00801741060557), received between Nov 18, 2016 and Jan 29, 2026 — classified as 2 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (35 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 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Material Rupture

  ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST 40 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 24208437 ↗
• MalfunctionJan 29, 2026Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE BY USING THE CONQUEST 40 PTA BALLOON. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALLOON ALLEGEDLY BURSTED BELOW 40 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207453 ↗
• MalfunctionDec 1, 2025Material Rupture; Material 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 23678240 ↗
• MalfunctionNov 3, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST 40 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS UNABLE TO INFLATE DUE TO LEAKAGE AND 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 23447531 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Device Dislodged or Dislocated; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE USING THE CONQUEST 40 PTA BALLOON, THE BALLOON PROTECTIVE PLASTIC TUBE WAS ALLEGEDLY STUCK. IT WAS FURTHER REPORTED THAT WHEN IT WAS PULLED, THE PLASTIC SHEATH CAME LOSE AT THE CLEAR PLASTIC HUB. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23400550 ↗
• MalfunctionSep 23, 2025Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  A FEMALE PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST 40 BALLOON CATHETER. DURING THE PROCEDURE WHEN REMOVING THE BALLOON TEAR WAS NOTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23120423 ↗
• MalfunctionAug 18, 2025Material Rupture; Material Rupture

  A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST 40 PTA BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS BURST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22824864 ↗
• MalfunctionAug 12, 2025Material Rupture; Material Rupture

  A PATIENT UNDERWENT A PTA PROCEDURE USING CONQUEST 40 BALLOON. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CONQUEST ALLEGEDLY BURST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783358 ↗
• MalfunctionMar 21, 2025Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED UPON INFLATION AT 20 ATM. IT WAS FURTHER REPORTED THAT WHEN THE BALLOON WAS PULLED, IT BECAME DISLODGED PARTIALLY FROM THE CATHETER SHAFT. REPORTEDLY, THE DISLODGED PORTION WAS ABLE TO BE GRABBED WITH FORCEPS AND EXTRACT FROM THE PATIENT AND THERE WAS A DIFFICULTY IN RETRACTING THE BALLOON THRU THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665723 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, WHEN INFLATING THE DEVICE, A GAP APPEARED AT THE PROXIMAL END OF THE BALLOON WHERE THE BALLOON AND SHAFT MEET. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21291642 ↗
• MalfunctionDec 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT CEPHALIC VEIN ARCH STENOSIS, DURING THE THIRD INFLATION, THE PTA BALLOON WAS ALLEGEDLY FOUND TO HAVE A LEAK AT 30 ATM UNDER DIGITAL SUBTRACTION ANGIOGRAPHY. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019265 ↗
• MalfunctionDec 10, 2024Difficult to Remove; Material Rupture; Failure to Advance; Device-Device Incompatibility; Difficult to Advance; Difficult to Remove; Material Rupture; Failure to Advance; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE IN THE CEPHALIC VEIN ARCH STENOSIS, THE PTA BALLOON ALLEGEDLY HAD A SLIGHT RESISTANCE TO FEEDING THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT THE PTA BALLOON ALLEGEDLY RUPTURED UPON OPENING DURING BALLOON DILATATION. FURTHERMORE, AFTER THE BALLOON RUPTURED, IT WAS ALLEGEDLY DIFFICULT TO RECOVER THE BALLOON THROUGH THE INTRODUCER SHEATH AND THERE WAS FRICTION, VIOLENT WITHDRAWAL. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20890171 ↗
• MalfunctionDec 10, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE IN THE CALCIFIED STENOSIS VIA THE UPPER ARM HIGH INTERNAL FISTULA AREA, THE PTA BALLOON ALLEGEDLY RUPTURED AT 8 ATM. IT WAS FURTHER REPORTED THAT IT WAS ALLEGEDLY DIFFICULT TO RECOVER THE BALLOON THROUGH THE INTRODUCER SHEATH. FURTHERMORE, THE RUPTURED BALLOON WAS WITHDRAWN. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20890107 ↗
• MalfunctionNov 2, 2024Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20594300 ↗
• MalfunctionOct 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR ARTERIOVENOUS FISTULA IN THE MIDDLE CEPHALIC VEIN, THE PTA 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 20488941 ↗
• MalfunctionOct 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE FOR ARTERIOVENOUS FISTULA IN THE MIDDLE CEPHALIC VEIN, THE PTA 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 20479947 ↗
• MalfunctionOct 14, 2024Break; Material Puncture/Hole; Break; Material Puncture/Hole

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON SHAFT WAS ALLEGEDLY BROKEN AND HAD A HOLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20447846 ↗
• MalfunctionJul 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY POPPED WHILE INFLATING. REPORTEDLY, 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 19824728 ↗
• MalfunctionSep 8, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE CEPHALIC ARCH LESION VIA THE RADIAL ARTERY, THE BALLOON ALLEGEDLY COULD NOT BE REMOVED FROM SHEATH. IT WAS FURTHER REPORTED THAT THE SHEATH AND BALLOON WAS REMOVED AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17709235 ↗
• MalfunctionFeb 28, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER ALLEGEDLY LEAKED DURING INFLATION OF THE BALLOON. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451782 ↗
• MalfunctionOct 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY BURST AT 30 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15613524 ↗
• MalfunctionAug 2, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258304 ↗
• MalfunctionApr 21, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698706 ↗
• MalfunctionApr 20, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE THROUGH A CALCIFIED SVC, THE BALLOON ALLEGEDLY BURST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698530 ↗
• MalfunctionMar 10, 2021Break; Leak/Splash; Material Puncture/Hole; Material Rupture; Break; Leak/Splash; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE ON LEFT UPPER ARM FISTULA VIA LEFT CEPHALIC ARCH APPROACH, THE BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449746 ↗