Conquest® 40 CQF5084Recalls & reported problems
Bard Peripheral Vascular, Inc. · Conquest® 40 PTA Dilatation Catheter 8 mm x 40 mm, 50 cm catheter · Class 2
All models of Conquest 40 (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741060267), received between Oct 3, 2017 and Mar 11, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 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.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
- Accessory Incompatible1
- Deflation Problem1
- Device-Device Incompatibility1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Intimal Dissection1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD A PINHOLE RUPTURE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY STARTED LEAKING AND NOT INFLATING. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21569687 ↗MalfunctionDec 12, 2024Accessory Incompatible; Failure to Advance; Device-Device Incompatibility; Accessory Incompatible; Failure to Advance; Device-Device Incompatibility
IT WAS REPORTED THAT THE WOUND DRAIN BALLOON WIRE WOULD NOT GO THROUGH THE CHANNEL, AND IT GETS STUCK ON SOMETHING. THE CUSTOMER HAD THE PRODUCT TO RETURN AND WOULD LIKE REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913213 ↗MalfunctionJul 16, 2020Deflation Problem; Deflation Problem
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CQF5084 PTA BALLOON DIALATION CATHETER ALLEGEDLY EXPERIENCED DEFLATION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10286571 ↗InjuryOct 3, 2017Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE PROXIMAL BASILIC VEIN, THE PTA BALLOON ALLEGEDLY RUPTURED ON THE FIRST INFLATION ATTEMPT. THE PTA BALLOON WAS EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. REPORTEDLY, A SMALL VESSEL DISSECTION OCCURRED POST BALLOON RUPTURE. PATIENT WAS REPORTED TO BE ASYMPTOMATIC POST PROCEDURE.
Patient problems: Intimal Dissection
MAUDE report 6911881 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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