Conquest® 40 CQF7586Recalls & reported problems
Bard Peripheral Vascular, Inc. · Conquest® 40 PTA Dilatation Catheter 8 mm x 60 mm, 75 cm catheter · Class 2
All models of Conquest 40 (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741060564), received between Jul 20, 2021 and Jan 24, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem2
- Break1
- Difficult to Remove1
- Entrapment of Device1
- Inflation Problem1
- Leak/Splash1
- Material Deformation1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2024Break; Leak/Splash; Material Split, Cut or Torn; Break; Leak/Splash; Material Split, Cut or Torn
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON SHAFT WAS ALLEGEDLY BROKEN NEAR THE DISTAL PLASTIC HUB. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18570975 ↗MalfunctionAug 9, 2023Deflation Problem; Entrapment of Device; Difficult to Remove; Material Deformation; Deflation Problem; Entrapment of Device; Difficult to Remove; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY FAILED TO DEFLATE. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY GOT STUCK INSIDE THE VESSEL AND WAS NOT EASILY REMOVED THROUGH THE SHEATH. REPORTEDLY, THE BALLOON WAS FORCED OUT THROUGH THE SHEATH WHILE BEING INFLATED AND REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17486673 ↗MalfunctionJul 20, 2021Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE PTA BALLOON ALLEGEDLY HAD AN INFLATION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12194693 ↗
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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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