Conquest® 40 CQF7588Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741060571), received between Dec 12, 2016 and Nov 5, 2024 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE BALLOON ALLEGEDLY RUPTURED AT 30 ATM. IT WAS FURTHER REPORTED THAT THERE WAS A LITTLE RESISTANCE TO REMOVE THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20608137 ↗
• MalfunctionJun 13, 2024Leak/Splash; Material Rupture; Material Deformation; Leak/Splash; Material Rupture; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE AT THE CEPHALIC ARCH, THE PTA BALLOON ALLEGEDLY HAD A LEAK UPON DEFLATION. REPORTEDLY, THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525923 ↗
• MalfunctionMay 30, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE PHYSICIAN USED A PERCUTANEOUS STICK TO POP THE BALLOON IN ORDER TO DEFLATE IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19432399 ↗
• MalfunctionMar 26, 2024Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF THE FISTULA VIA THE DISTAL CEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 20 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984432 ↗
• MalfunctionNov 20, 2023Break; Leak/Splash; Material Rupture; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Leak/Splash; Material Rupture; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF THE BASILIC SWING SEGMENT STENOSIS VIA THE LEFT UPPER ARM, THE TIP OF THE PTA BALLOON CATHETER ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT CONTRAST LEAKAGE HAD ALLEGEDLY APPEARED TO BE NOTED ON THE END OF THE BALLOON CLOSE TO THE TIP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18168275 ↗
• MalfunctionJan 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED AT APPROXIMATELY 15 ATM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095099 ↗
• MalfunctionJun 2, 2022Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14572945 ↗
• MalfunctionJul 16, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE AND DIFFICULT TO REMOVE. IT WAS FURTHER REPORTED THAT BALLOON DEFLATED USING NEEDLE STICK PUNCTURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178989 ↗
• MalfunctionOct 13, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PTA PROCEDURE, THE CATHETER WAS 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 10668509 ↗
• InjuryApr 1, 2020Deflation Problem; Material Deformation; Deflation Problem; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE BRACHIAL ARTERY, THE PTA BALLOON ALLEGEDLY COULD NOT BE FULLY DEFLATED. IT WAS FURTHER REPORTED THAT A NEEDLE STICK WAS USED TO PERCUTANEOUSLY DEFLATE THE BALLOON. THE BALLOON WAS REMOVED FROM THE PATIENT AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO FURTHER REPORTED COMPLICATIONS TO THE PATIENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9914190 ↗
• MalfunctionJul 22, 2019Retraction Problem; Unraveled Material; Retraction Problem; Unraveled Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF7588 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A RETRACTION PROBLEM AND UNRAVELED MATERIAL. THERE WAS NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE PATIENT WAS A 46-YEAR-OLD MALE WHO WEIGHED 234 POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813089 ↗
• MalfunctionJul 19, 2019Material Frayed; Material Rupture; Material Frayed; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF7588 PTA BALLOON DILATATION CATHETER ALLEGEDLY RUPTURED AT APPROXIMATELY 25 ATMOSPHERES. THERE WAS NO REPORTED RETRACTION DIFFICULTY THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE PATIENT WAS A (B)(6) YEAR-OLD MALE WHO WEIGHED (B)(6) KILOGRAMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808999 ↗
• MalfunctionMay 14, 2019Entrapment of Device; Failure to Advance

  AFTER BALLOONING, THE SURGEON WAS REMOVING THE BALLOON CATHETER AND A FIBER CAUGHT THE END OF STENT AND MOVED IT. THE SURGEON WAS ABLE TO PUT STENT BACK INTO PLACE. NOTES FROM OPERATIVE REPORT: ...25 CM 4 FRENCH SHEATH WAS INSERTED IN HOBBS JUST PROXIMAL TO THE AREA OF PRE-EXISTING STENT. USING A BERENSTEIN CATHETER SUPPORT AND STIFF GLIDEWIRE, THE AREA OF THE PREVIOUSLY STENTED PORTION WAS ABLE TO BE CROSSED AND THE WIRE PLACED PAST THE VENTRICLE INTO PORTION OF IVC (INFERIOR VENA CAVA). AS NOW THE PLAN WAS TO TREAT THIS AREA WITH STENT GRAFT PLACEMENT AS WELL AS ANGIOPLASTY, THE SHEATH WAS UPSIZED TO 7 FRENCH BY 25 CM SHEATH. THE AREA WAS PREDILATED USING 6 MM X 100 MM ANGIOPLASTY BALLOON (CONQUEST, BARD). THIS THEN ALLOWED FOR A LARGER BALLOON ANGIOPLASTY USING 8 MM X 80 MM ANGIOPLASTY (CONQUEST, BARD). SUBSEQUENT TO THIS, AN ATTEMPT WAS MADE TO PASS THE FLUENCY STENT GRAFT. HOWEVER, THE DISTAL PORTION OF THE PRE-EXISTING STENTS HAD ONE OF THE STRUTS THAT WAS PREVENTING THE PASSAGE OF THE STENT GRAFT. THEREFORE, STRONGER SUPPORT WAS OBTAINED BY SWITCHING TO SUPERCORE WIRE. DURING THIS PROCESS, VENOGRAM WAS PERFORMED AT THE LEVEL OF THE VENA CAVA AND MULTIPLE POINTS, AND IT WAS N

  Patient problems: Occlusion

  MAUDE report 8607363 ↗
• InjuryDec 27, 2017Deflation Problem; Retraction Problem; Deflation Problem; Retraction Problem

  IT WAS REPORTED THAT AFTER THE FIRST INFLATION IN THE CEPHALIC ARCH, THE PTA BALLOON ALLEGEDLY WOULD NOT DEFLATE. THE HEALTH CARE PROVIDER PULLED THE CATHETER UP INTO THE SHOULDER REGION AND USED A NEEDLE STICK THROUGH THE SKIN TO DEFLATE THE BALLOON. IT WAS FURTHER REPORTED THAT DURING RETRACTION THROUGH THE SHEATH, THE BALLOON CATHETER ALLEGEDLY BECAME LODGED. THE CATHETER AND SHEATH WERE REMOVED TOGETHER AS A SINGLE UNIT WITHOUT FURTHER INCIDENT. REPORTEDLY, ANOTHER BALLOON CATHETER AND SHEATH WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED AS ASYMPTOMATIC POST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7149036 ↗
• MalfunctionDec 15, 2017Device Packaging Compromised; Packaging Problem; Device Packaging Compromised; Packaging Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, A HOLE WAS FOUND IN THE INNER PACKAGING SLEEVE. ANOTHER BALLOON WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7121576 ↗
• MalfunctionDec 12, 2016Material Frayed; Material Rupture; Material Frayed; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A NON-CALCIFIED LESION IN THE CEPHALIC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM ON THE FIRST INFLATION. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER BALLOON THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO RETRACTION ISSUES REPORTED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6167031 ↗