IMPRA ePTFE Vascular GraftsRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 52 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 144
- Deaths reported
- 0
- Injuries reported
- 57
- Recalls
- 0
We found 52 models of IMPRA ePTFE Vascular Grafts by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 144 adverse event reports in the FDA's MAUDE database, received between Sep 12, 2016 and Mar 10, 2026 — classified as 57 injuries, 87 malfunctions.
The most frequently reported specific device problem is “Torn Material” (32 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 IMPRA ePTFE Vascular Grafts problems
Device problems
- Torn Material32
- Material Split, Cut or Torn29
- Obstruction of Flow28
- Leak/Splash25
- Occlusion Within Device19
- Adverse Event Without Identified Device or Use Problem16
- Device Contamination with Chemical or Other Material3
- Material Separation3
Patient problems
- No Consequences Or Impact To Patient35
- No Clinical Signs, Symptoms or Conditions32
- Thrombosis28
- No Patient Involvement22
- Stenosis21
- Thrombosis/Thrombus7
- Unspecified Infection6
- Hematoma5
IMPRA ePTFE Vascular Grafts models
52 models, most reported first. Each model has its own page with its reports, recalls and device details.
- IMPRA® ePTFE Vascular Grafts 40S06PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER49 reports
- IMPRA® ePTFE Vascular Grafts F8006TWSCPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER7 reports
- IMPRA® ePTFE Vascular Grafts F7006TWSCPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER6 reports
- IMPRA® ePTFE Vascular Grafts F8008TWSCPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER5 reports
- IMPRA® ePTFE Vascular Grafts F7008TWSPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER5 reports
- IMPRA® ePTFE Vascular Grafts F5008TWSCPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER4 reports
- IMPRA® ePTFE Vascular Grafts F7006TWSPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER4 reports
- IMPRA® ePTFE Vascular Grafts F7007TWSPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER4 reports
- IMPRA® ePTFE Vascular Grafts F7007TWSCPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER3 reports
- IMPRA® ePTFE Vascular Grafts 10S035PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER3 reports
- IMPRA® ePTFE Vascular Grafts 40S06CPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- IMPRA® ePTFE Vascular Grafts 50S06CPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER2 reports
- IMPRA® ePTFE Vascular Grafts CFT4547CPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- IMPRA® ePTFE Vascular Grafts 40A64CPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER2 reports
- IMPRA® ePTFE Vascular Grafts 10S05TWCPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- IMPRA® ePTFE Vascular Grafts F5006CPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER2 reports
- IMPRA® ePTFE Vascular Grafts F5006TWSCPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER2 reports
- IMPRA® ePTFE Vascular Grafts F7008TWSCPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- IMPRA® ePTFE Vascular Grafts F8007TWSCPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER2 reports
- IMPRA® ePTFE Vascular Grafts CF4006PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- IMPRA® ePTFE Vascular Grafts 40A74PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- IMPRA® ePTFE Vascular Grafts 10S03PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- IMPRA® ePTFE Vascular Grafts 40S05CPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts 40S07CPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts 40S08CPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts CF4006CPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts 40A74CPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts CF40A74CPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts 70S08CPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts 80S06CPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts 10S06TWCPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts 40S06TWCPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts 50S08TWCPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts 70S06TWCPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts F8008CPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts F5006SCPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts F3006TWSCPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts F3008TWSCPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts 70T74TWCPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts 45A64PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts CF40A64PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts 80S08PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts 10S16PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts 10S19PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts 70S08TWPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts F4006PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts F4007PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts F4008PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts F7006TWPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts F5006TWSPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts F8006TWSPROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
- IMPRA® ePTFE Vascular Grafts 10S04PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 report
Recent IMPRA ePTFE Vascular Grafts adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Fluid/Blood Leak; Leak/Splash; Peeled/Delaminated; Material Split, Cut or Torn
ON (B)(6) 2026, A PATIENT UNDERWENT A SURGICAL GRAFT PLACEMENT PROCEDURE USING A CARBOFLO DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE RING ON THE GRAFT ALLEGEDLY FELL OFF, CAUSING THE BLOOD TO LEAK FROM THE GRAFT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24554738 ↗MalfunctionDec 11, 2025Improper or Incorrect Procedure or Method; Separation Failure; Improper or Incorrect Procedure or Method; Separation Failure
ON (B)(6) 2025, A PATIENT UNDERWENT A SURGICAL GRAFT PLACEMENT PROCEDURE USING THE CARBOFLO. DURING THE PROCEDURE THE CLINICIAN WAS UNABLE TO REMOVE THE SPIRAL BEADING FROM GRAFT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776878 ↗MalfunctionDec 11, 2025Improper or Incorrect Procedure or Method; Separation Failure; Improper or Incorrect Procedure or Method; Separation Failure
ON (B)(6) 2025, A PATIENT UNDERWENT A SURGICAL GRAFT PLACEMENT PROCEDURE USING THE CARBOFLO. DURING THE PROCEDURE THE CLINICIAN WAS UNABLE TO REMOVE THE SPIRAL BEADING FROM GRAFT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776876 ↗MalfunctionOct 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A PATIENT WAS GETTING PREPARED FOR A SURGICAL GRAFT PLACEMENT PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE MATERIAL TORE REPEATEDLY WHILE STITCHING. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23298301 ↗MalfunctionJul 22, 2025Leak/Splash; Leak/Splash
ON (B)(6) 2025, A PATIENT UNDERWENT A SURGICAL GRAFT PLACEMENT PROCEDURE, THE GRAFT ALLEGEDLY LEAKING UP NORMALLY AT THE SITE OF STITCHING. PHYSICIAN HAD TO ADD PATCH THE SITE, TO STOP THE LEAK. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22563434 ↗MalfunctionJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE GRAFT ALLEGEDLY HAD TRAUMA AND SWEATING, WHICH WAS NOT IN THE ANASTOMOSIS AREA. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21077073 ↗MalfunctionDec 28, 2023Material Too Rigid or Stiff; Material Split, Cut or Torn; Material Too Rigid or Stiff; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A SURGICAL GRAFT IMPLANTATION PROCEDURE, THE MATERIAL ALLEGEDLY HAD A DIFFERENT TEXTURE AND WAS MORE RIGID. IT WAS FURTHER REPORTED THAT DEVICE ALLEGEDLY HAD SMALL CRACKS, MAKING IT IMPOSSIBLE TO USE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18407427 ↗MalfunctionOct 23, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT PRIOR TO A SURGICAL GRAFT PLACEMENT PROCEDURE, THE EXPIRATION DATE IN THE QUALITY CERTIFICATE WAS ALLEGEDLY FOUND TO BE DIFFERENT THAN THE EXPIRATION DATE IN THE ACTUAL PRODUCT PACKAGE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17987131 ↗MalfunctionOct 13, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A SURGICAL GRAFT PLACEMENT PROCEDURE, THE GRAFT WAS ALLEGEDLY FOUND TO BE SPLIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17929050 ↗MalfunctionAug 13, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT SOMETIMES POST SURGICAL GRAFT PLACEMENT PROCEDURE, THE GRAFT HAD TO BE REMOVED AT THE END OF THE PROCEDURE WHEN BLEEDING WAS OBSERVED. IT WAS FURTHER REPORTED THAT THE GRAFT WAS ALLEGEDLY TEARING APART LIKE PAPER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17538037 ↗MalfunctionJul 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT POST-SURGICAL GRAFT IMPLANTATION IN ATRIOVENTRICULAR FISTULA, THE BLOOD VESSELS LEAKED BLOOD. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17409136 ↗MalfunctionJul 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT POST-SURGICAL GRAFT IMPLANTATION IN ATRIOVENTRICULAR FISTULA, THE BLOOD VESSELS LEAKED BLOOD. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17409125 ↗MalfunctionJul 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT POST A SURGICAL GRAFT PLACEMENT PROCEDURE, THE BLOOD VESSELS ALLEGEDLY LEAKED BLOOD. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17403539 ↗MalfunctionJul 27, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT POST A SURGICAL GRAFT PLACEMENT PROCEDURE, THE BLOOD VESSELS ALLEGEDLY LEAKED BLOOD. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17403502 ↗MalfunctionJun 14, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A SURGICAL GRAFT PLACEMENT PROCEDURE, THE SURGICAL GRAFT ALLEGEDLY SPLIT DURING THE PROCESS OF SUTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17123360 ↗
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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