GORE PROPATEN Vascular Graft H470045ARecalls & reported problems
W. L. Gore & Associates, Inc. · PROPATEN VASCULAR GRAFT SW 4-7mmX45cm Tapered Heparin · Class 2 · Implant
All models of GORE PROPATEN Vascular Graft (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132605958), received between Nov 20, 2018 and Oct 4, 2019 — classified as 1 death, 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- Death1
- Exsanguination1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
THE FOLLOWING WAS REPORTED TO GORE: THE GORE® PROPATEN® VASCULAR GRAFT WAS IMPLANTED ON (B)(6) 2019 IN THE GROIN. ON (B)(6) 2019 THE DEVICE WAS EXPLANTED BECAUSE OF INFECTION.
Patient problems: Unspecified Infection
MAUDE report 9158382 ↗DeathNov 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
GORE RECEIVED MEDWATCH # (B)(4) FROM FDA REPORTING THE FOLLOWING: THE PATIENT HAD A 3.75 HOUR HEMODIALYSIS TREATMENT THAT WAS TERMINATED AT APPROXIMATELY 11:00AM. PER THE ER ADMISSION SUMMARY, THE PATIENT WAS AT HOME WITH HIS SPOUSE, WHO HAD LEFT THE ROOM. WHEN SHE RETURNED, THE PATIENT WAS FOUND UNRESPONSIVE AND BLEEDING FROM HIS AV GRAFT. 911 WAS CALLED AND THE PATIENT WAS TRANSPORTED TO THE ER AND ADMITTED AT 16:11 WHERE IV FLUIDS AND 2 PACKED RED BLOOD CELLS (PRBC) ADMINISTERED. THE PATIENT WAS INTUBATED. HE SUSTAINED A CARDIOPULMONARY ARREST (CPA) IN THE ER. THE HOSPITAL WAS IN THE PROCESS OF TRANSFERRING PATIENT TO ANOTHER HOSPITAL AFTER RESUSCITATION. DURING TRANSFER TO THE AMBULANCE, THE PATIENT CODED AND SUBSEQUENTLY EXPIRED.
Patient problems: Death; Exsanguination
MAUDE report 8103304 ↗
Other PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER devices
- Cardioroot HEWROOT0030Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths13 reports
- FLIXENE SLIDER GDS 25058Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall13 reports
- ADVANTA SLIDER GDS 22114Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall11 reports
- Cardioroot HEWROOT0032Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths10 reports
- FLIXENE SLIDER GDS 25129Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall9 reports
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25138Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall7 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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