Gelweave™ 733032Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis STRAIGHT · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 05037881106878), received between Nov 25, 2020 and Jul 11, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Thrombosis/Thrombus1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLINICAL STUDY: (B)(6). EVENT DATE: 27 NOV 2022. IMPLANT DATE: (B)(6) 2019. EVENT: ARTERIAL OR VENOUS THROMBOSIS WITH NO MEDICAL HISTORY. ON (B)(6) 2022 PATIENT WAS ADMITTED TO (B)(6) MEDICAL CENTER TO UNDERGO SURGICAL INTERVENTION FOR HER CARDIOTHORACIC DIAGNOSIS OF PARTIALLY THROMBOSED ASCENDING PSEUDOANEURYSM AND NEW 5.9CM EXTENT TYPE III TAAA. THE THROMBOSIS WAS LOCATED IN THE VESSEL. OVERALL, THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT SIGNIFICANT DIFFICULTY OR EVIDENT COMPLICATION, AND WAS TRANSFERRED TO THE CARDIOTHORACIC SURGICAL INTENSIVE CARE UNIT. IN THE IMMEDIATE POSTOPERATIVE PERIOD, SHE CONTINUED TO DO PROGRESS WELL. ULTIMATELY, SHE WAS TRANSFERRED TO THE STEP-DOWN UNIT FOR THE REMAINDER OF HER HOSPITAL COURSE. AFTER DISCUSSION WITH THE CASE MANAGER, PATIENT AND FAMILY; THE DECISION WAS MADE TO HAVE PATIENT DISCHARGE TO HOME (B)(6) 2022. THIS WAS AN UNANTICIPATED EVENT, MEDICATION & SURGICAL INTERVENTION WAS CARRIED OUT- TRANSCERVICAL RETROPHARYNGEAL CAROTID TO CAROTID TO SUBCLAVIAN BYPASS WAS PERFORMED. PATIENT OUTCOME: RESOLVED WITH SEQUELAE ON (B)(6) 2022. THIS REPORT IS BEING SUBMITTED AS A FOLLOW-UP FOR MANUFACTURING REPORT #9612515-2024-00047 TO PROVIDE EVE
Patient problems: Thrombosis/Thrombus
MAUDE report 19719135 ↗MalfunctionNov 25, 2020Material Puncture/Hole; Material Puncture/Hole
ON (B)(6) 2020 THE CLINICIAN HAD JUST IMPLANTED THE GELWEAVE GRAFT AND RELEASED THE CLAMP FORM THE AORTA, A SMALL 2MM TEAR WAS OBSERVED NEAR THE ANASTOMOSIS (2CM). THE TEAR WAS REPAIRED USING 5.0 PROLINE SUTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE EVENT WAS REPORTED AS DEVICE RELATED AND POSSIBLY PROCEDURAL RELATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10903463 ↗
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
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- ADVANTA SLIDER GDS 22222Atrium 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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