IMPRA® ePTFE Vascular Grafts 40A64CRecalls & reported problems
Bard Peripheral Vascular, Inc. · IMPRA® ePTFE Vascular Graft, Carboflo® Short Tapered Carbon-Lined, 6-4 mm x 40 cm · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741020995), received between Jun 4, 2018 and Aug 15, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
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.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING AN ANGIOGRAPHY APPROXIMATELY 50 DAYS POST PROCEDURE, THE INNER LUMEN SURFACE OF THE VASCULAR GRAFT WAS ALLEGEDLY NOT SMOOTH AND SOMETHING TATTERED WAS FOUND. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER (HCP) PUNCTURED THE GRAFT AND ALLEGEDLY RETRIEVED A FILM-LIKE SUBSTANCE. REPORTEDLY, A SECOND PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE VASCULAR GRAFT WITH ANOTHER. UPON COMPLETION OF THE SECOND PROCEDURE, THE HCP RECANTED THE ALLEGATION OF FOREIGN MATERIAL AS IT DID NOT ORIGINATE FROM THE GRAFT. THE PATIENT WAS REPORTED AS RECOVERING THROUGH DIALYSIS WITH HD CATHETER POST SECOND PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7787478 ↗MalfunctionJun 4, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE MIDDLE PART OF THE VASCULAR GRAFT ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7567485 ↗
Other PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER devices
- ADVANTA SLIDER GDS 22115Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall9 reports
- ADVANTA SLIDER GDS 22116Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall1 report
- ADVANTA SLIDER GDS 22061Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall0 reports
- ADVANTA SLIDER GDS 22011Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall0 reports
- ADVANTA SLIDER GDS 22267Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall0 reports
- ADVANTA SLIDER GDS 22016Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall0 reports
- ADVANTA SLIDER GDS 22058Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER1 recall0 reports
- IMPRA® ePTFE Vascular Grafts F8006TWSCBard Peripheral Vascular, Inc. · PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER7 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.