Conquest 40Recalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 313
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 25 models of Conquest 40 by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 313 adverse event reports in the FDA's MAUDE database, received between Oct 12, 2016 and Sep 29, 2026 — classified as 12 injuries, 301 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (160 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Conquest 40 problems
Device problems
- Material Rupture160
- Deflation Problem108
- Difficult to Remove33
- Material Frayed32
- Retraction Problem30
- Break18
- Inflation Problem18
- Peeled/Delaminated14
Patient problems
- No Clinical Signs, Symptoms or Conditions162
- No Consequences Or Impact To Patient135
- Needle Stick/Puncture4
- No Patient Involvement4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Known Impact Or Consequence To Patient2
- Perforation of Vessels2
- Foreign Body In Patient1
Conquest 40 models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Conquest® 40 CQF7584CATHETER, PERCUTANEOUS74 reports
- Conquest® 40 CQF7574CATHETER, PERCUTANEOUS55 reports
- Conquest® 40 CQF75124CATHETER, PERCUTANEOUS41 reports
- Conquest® 40 CQF75104Catheter, angioplasty, peripheral, transluminal32 reports
- Conquest® 40 CQF7564CATHETER, PERCUTANEOUS24 reports
- Conquest® 40 CQF7588Catheter, angioplasty, peripheral, transluminal16 reports
- Conquest® 40 CQF7594Catheter, angioplasty, peripheral, transluminal11 reports
- Conquest® 40 CQF7554CATHETER, PERCUTANEOUS10 reports
- Conquest® 40 CQF75108Catheter, angioplasty, peripheral, transluminal9 reports
- Conquest® 40 CQF5074Catheter, angioplasty, peripheral, transluminal7 reports
- Conquest® 40 CQF7598CATHETER, PERCUTANEOUS6 reports
- Conquest® 40 CQF5064CATHETER, PERCUTANEOUS5 reports
- Conquest® 40 CQF5084Catheter, angioplasty, peripheral, transluminal4 reports
- Conquest® 40 CQF7578Catheter, angioplasty, peripheral, transluminal4 reports
- Conquest® 40 CQF7586CATHETER, PERCUTANEOUS3 reports
- Conquest® 40 CQF75810CATHETER, PERCUTANEOUS3 reports
- Conquest® 40 CQF7544CATHETER, PERCUTANEOUS1 report
- Conquest® 40 CQF7552CATHETER, PERCUTANEOUS1 report
- Conquest® 40 CQF7568CATHETER, PERCUTANEOUS1 report
- Conquest® 40 CQF75610Catheter, angioplasty, peripheral, transluminal1 report
- Conquest® 40 CQF7576CATHETER, PERCUTANEOUS1 report
- Conquest® 40 CQF7582Catheter, angioplasty, peripheral, transluminal1 report
- Conquest® 40 CQF7583Catheter, angioplasty, peripheral, transluminal1 report
- Conquest® 40 CQF75102Catheter, angioplasty, peripheral, transluminal1 report
- Conquest® 40 CQF75122CATHETER, PERCUTANEOUS1 report
Recent Conquest 40 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Detachment of Device or Device Component
On (b)(6) 2026, a 64-year-old male patient was prepared for a percutaneous transluminal angioplasty (PTA) procedure using a Conquest 40 balloon catheter via a right arm arteriovenous fistula. Prior to patient use, during device preparation, the Conquest balloon catheter was advanced through the sheath; however, the balloon failed to inflate, and fluid leakage was observed from the hub due to a crack. It was further reported that a complete fracture of the balloon catheter was identified. The device was not used on the patient. The procedure was subsequently completed using another balloon catheter, resulting in a procedural delay. There was no reported patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927852 ↗MalfunctionSep 28, 2026Material Rupture
On (b)(6) 2026, a patient underwent an angioplasty procedure using a Conquest 40 PTA balloon. During the procedure, the balloon was successfully inflated to dilate a stent. After deflation and withdrawal for repositioning to another treatment site, the physician attempted to reinflate the balloon but observed that it would not maintain pressure. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911163 ↗MalfunctionAug 7, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50170258 ↗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 31, 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. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433749 ↗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 ↗MalfunctionOct 8, 2025Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE CONQUEST 40 PTA BALLOON. DURING THE PROCEDURE, THE BALLOON ALLEGEDLY INVERTED ALONG THE PROXIMAL SEGMENT. IT WAS FURTHER REPORTED THAT IT COULD NOT BE REMOVED FROM THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23244009 ↗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 ↗MalfunctionSep 22, 2025Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem
ON (B)(6) 2025, A PATIENT UNDERWENT FORA ANGIOPLASTY PROCEDURE USING CONQUEST 40. PIOR TO AN ANGIOPLASTY PROCEDURE USING THE CONQUEST 40 PTA BALLOON, INNER AND OUTER PACKAGES ALLEGEDLY ARRIVED WET. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23107239 ↗MalfunctionSep 12, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE CONQUEST 40 PTA BALLOON. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PACKAGING ALLEGEDLY HAVE WATER DAMAGE. IT WAS FURTHER REPORTED THAT THE WATER MARK IS BELOW THE STERILE PACKAGE LINE. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23037208 ↗InjurySep 2, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, THE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE UTILIZING THE CONQUEST 40 PTA BALLOON. DURING THIS PROCEDURE, THE BALLOON REPORTEDLY RUPTURED. THE PATIENT IS SAID TO HAVE EXPERIENCED A VESSEL RUPTURE AND SUBSEQUENT BLEEDING. IT HAS BEEN REPORTED THAT ANOTHER BALLOON WAS EMPLOYED TO FINALIZE THE PROCEDURE. THE CURRENT STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 22931792 ↗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 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- DENALI Vena Cava Filter2 models · 1,021 reports
- MAGNUM19 models · 571 reports · 1 recall
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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