Conquest® 40 CQF5074Recalls & reported problems
Bard Peripheral Vascular, Inc. · Conquest® 40 PTA Dilatation Catheter 7 mm x 40 mm, 50 cm catheter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741060205), received between Oct 12, 2023 and Jul 4, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (6 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.
Reports received per month
Most reported problems
Device problems
- Material Rupture6
- Difficult to Remove5
- Device-Device Incompatibility1
- Difficult to Open or Remove Packaging Material1
- Failure to Advance1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 4, 2025Difficult to Remove; Failure to Advance; Device-Device Incompatibility; Difficult to Remove; Failure to Advance; Device-Device Incompatibility
ON (B)(6) 2025, A 60-YEAR-OLD MALE PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST 40 PTA BALLOON CATHETER FOR CEPHALIC VEIN FISTULA. DURING THE PROCEDURE, THE BALLOON CATHETER ALLEGEDLY CANNOT REWIRE. IT WAS FURTHER REPORTED THAT 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 22402853 ↗MalfunctionJan 10, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON WAS ALLEGEDLY RUPTURED AT 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 21121858 ↗MalfunctionDec 26, 2024Inflation Problem; Difficult to Remove; Material Rupture; Difficult to Open or Remove Packaging Material; Inflation Problem; Difficult to Remove; Material Rupture; Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD SOME RESISTANCE TO REMOVE THE BALLOON PROTECTOR. REPORTEDLY, THE PTA BALLOON RUPTURED AT 8 ATM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21016831 ↗MalfunctionNov 20, 2023Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY LEAKED LIQUID DURING THE INFLATION. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY RUPTURED. FURTHERMORE, IT WAS ALSO REPORTED THAT THERE WAS AN ALLEGED RESISTANCE FELT WHEN RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH FOLLOWING THE BALLOON RUPTURE AND WERE RETRIEVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18167854 ↗MalfunctionNov 20, 2023Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY LEAKED LIQUID DURING THE INFLATION. IT WAS FURTHER REPORTED THAT THE BALLOON WAS ALLEGEDLY RUPTURED. FURTHERMORE, IT WAS ALSO REPORTED THAT THERE WAS AN ALLEGED RESISTANCE FELT WHEN RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH FOLLOWING THE BALLOON RUPTURE BUT WERE RETRIEVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18167822 ↗MalfunctionOct 18, 2023Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY RUPTURED DURING DILATION. FURTHER IT WAS REPORTED THAT THE BALLOON FELT RESISTANCE WHEN RETRIEVING THROUGH THE SHEATH BUT WAS REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17954834 ↗MalfunctionOct 12, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON 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 17920923 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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