GelweaveRecalls & reported problems across all models
Vascutek Ltd · 47 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 87
- Deaths reported
- 6
- Injuries reported
- 38
- Recalls
- 0
We found 47 models of Gelweave by Vascutek Ltd in the FDA's device registry (GUDID). Together they are named in 87 adverse event reports in the FDA's MAUDE database, received between Aug 29, 2016 and Sep 11, 2026 — classified as 6 deaths, 38 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (21 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 Gelweave problems
Device problems
- Material Integrity Problem21
- Insufficient Device Problem Information15
- Adverse Event Without Identified Device or Use Problem10
- Fluid/Blood Leak8
- Leak/Splash8
- Material Puncture/Hole8
- Obstruction of Flow8
- Device Handling Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Fever9
- Insufficient Information8
- No Known Impact Or Consequence To Patient8
- Hemorrhage/Blood Loss/Bleeding7
- Seroma6
- Aneurysm5
- No Information5
Gelweave models
47 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Gelweave™ 731508PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER7 reports
- Gelweave™ 733008PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 death7 reports
- Gelweave™ 730030ADPPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 death6 reports
- Gelweave™ 732032PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER4 reports
- Gelweave™ 734028/10ADPPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER4 reports
- Gelweave™ 73261088/8PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 death3 reports
- Gelweave™ 735028/8SPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER3 reports
- Gelweave™ 731608XL55PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER3 reports
- Gelweave™ 73261088/10SAPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER3 reports
- Gelweave™ 733010PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- Gelweave™ 732030PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- Gelweave™ 731608PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- Gelweave™ 733032PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- Gelweave™ 733038PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- Gelweave™ 732410108/8S4PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- Gelweave™ 732211XL55PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 death2 reports
- Gelweave™ 730032ADPPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- Gelweave™ 73221088/10SAPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- Gelweave™ 73201088/10SAPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 734026CX4RMSPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 732038PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 736012PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 735020PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 734030PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 732010PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 732412PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 734026/8PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 734034/10PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 73241088/8PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 death1 report
- Gelweave™ 73301088/8PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 73321088/8PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 73341088/8PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 73261088/10PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 734024/10SPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 734026/10SPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 735026/8SPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 death1 report
- Gelweave™ 733028PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 732810108/8S4PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 731407XL55PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 731809XL55PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 732010XL55PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 730026ADPPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 734026/10ADPPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 73261088/10RMPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 73241088/10RMPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 73341088/8RMPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelweave™ 732012/8X2PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
Recent Gelweave adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Fluid/Blood Leak
Blood leakage: Blood leakage was identified at the anastomosis between the collar and the main vessel graft. There were no issues during cardiopulmonary bypass. However, after the aortic cross-clamp was released, bleeding occurred and could not be stopped. Hemostasis was achieved by using a large amount of haemostatic agents. Then, the chest was closed. Although the procedure time was extended due to the time it took to achieve hemostasis, the procedure was successfully completed.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50730737 ↗InjuryAug 27, 2026Fluid/Blood Leak
Event was reported as Blood leakage:Redo descending aortic replacement was performed on the patient with ET (Essential Thrombocythaemia) who underwent the Gelweave implantation on (b)(6) 2026. During the procedure, significant blood leakage from the Gelweave was noted. Despite the administration of protamine, there was still significant leakage from the Gelweave, making it difficult to achieve hemostasis. Although nearly two hours passed, hemostasis could not be achieved.Therefore, three SURGIFLO hemostatic matrix kits (Johnson & Johnson) were used, and a SURGICEL absorbable hemostat (Johnson & Johnson) was placed firmly on the bleeding site. Then, the chest was closed. Doctor's comment:Blood leakage occurred from the Gelweave implanted on (b)(6) 2026. Due to the difficulty of achieving homeostasis during the redo procedure because of the leakage, the applicability of Gelweave for patients who will undergo a redo procedure must be considered. It would be difficult to use Gelweave unless the cause of this event is identified because I will not be able to provide patients with reasonable explanations about the devices that will be used during the procedure.There was no health damage
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50470954 ↗MalfunctionJul 15, 2026
WE OPENED THE GELWEAVE GELATIN WOVEN VASCULAR PROSTHESIS. PER DR. [REDACTED] IT WAS FALLING APART; SHE DECIDED TO NOT USE THE GRAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25825120 ↗InjuryJul 1, 2026Fluid/Blood Leak
EVENT REPORTED AS BLOOD LEAKAGE, AFTER PERFORMING THE DISTAL ANASTOMOSIS, THE DOCTOR CHECKED FOR HEMOSTASIS. HOWEVER, LEAKAGE WAS OBSERVED FROM THE MAIN BODY OF THE GRAFT. THE DOCTOR USED A SURGIFLO (JOHNSON & JOHNSON), A HEMOSTATIC AGENT, TO ADDRESS THE LEAKAGE. HEMOSTASIS WAS ACHIEVED AND THE PROCEDURE WAS COMPLETED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25677531 ↗InjuryMay 13, 2026No Apparent Adverse Event; Insufficient Device Problem Information
INCIDENT WAS RECEIVED FROM THE PATIENT'S LEGAL REPRESENTATIVE AND A SUMMARY OF THE INCIDENT INFORMATION IS STATED BELOW: ON THE EVENING OF (B)(6) 2024, A FEW HOURS AFTER THE INTERVENTION DESCRIBED AS "REPLACEMENT OF THE ASCENDING AORTA WITH A DACRON PROSTHESIS OF 38 MM DIAMETER WITH REINFORCEMENT OF PROXIMAL AND DISTAL ANASTOMOSES USING ACUSEAL STRIPS AND BIO GLUE SURGICAL ADHESIVE UNDER EXTRACORPOREAL CIRCULATION (ECC)," MY WIFE BEGAN RECEIVING AUTOMATIC SMS MESSAGES STATING, "MRI STROKE." AS NO ONE HAD INFORMED HER THAT I WAS IN A SERIOUS, UNCONSCIOUS CONDITION, SHE CALLED THE HOSPITAL, WHERE ICU STAFF INFORMED HER THAT, I HAD SUFFERED 7 STROKES."CONSIDERING THE CARDIO-EMBOLIC NATURE OF THE EVENTS, THE NUMBER OF 7 STROKES, AND THE CONTEXT OF SURGERY INVOLVING IMPLANTATION OF PROSTHETIC MATERIALS AND USE OF SURGICAL ADHESIVES, THERE IS A HIGH MEDICAL PROBABILITY THAT THE EMBOLIC SOURCE WAS THE FORMATION OF A THROMBUS DIRECTLY RELATED TO THE IMPLANTED MEDICAL DEVICES OR THEIR MATERIAL. AS A RESULT OF THE INCIDENT THE PATIENT IS REPORTING AN "INABILITY TO WORK AND PERMANENT BLINDNESS". THIS EVENT OCCURED WHEN THE PATIENT WAS HOSPITALISED IN (B)(6).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Stroke/CVA
MAUDE report 25158761 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
EVENT REPORTED FROM PANTHER STUDY (NCT04545502) AS PSEUDOANEURYSM. THE PATIENT WAS A 53-YEAR-OLD, BLACK, MALE WITH CHRONIC DISSECTION, UNDERWENT OPEN SURGICAL REPAIR OF THE THORACOABDOMINAL AORTA WITH A GELWEAVE THORACOABDOMINAL COSELLI GRAFT ON (B)(6) 2025. POST-OPERATIVELY (ON POD 121 - ON (B)(6) 2026), THE PATIENT PRESENTED WITH THE SERIOUS ADVERSE EVENT OF PSEUDOANEURYSM. CT ANGIOGRAPHY SHOWED ARTERIAL EXTRAVASATION FROM THE DISTAL AORTIC GRAFT WITH ENLARGING LEFT PLEURAL HEMATOMA. THE PATIENT UNDERWENT EMERGENT TEVAR AND EVAR ON (B)(6) 2026, AND THE EVENT WAS CONSIDERED RESOLVED WITH SEQUELAE. THE SITE CONFIRMED THAT THE REINTERVENTION WAS NOT REQUIRED AS A RESULT OF ANY DEVICE DEFICIENCY.
Patient problems: Pseudoaneurysm
MAUDE report 24555356 ↗DeathJan 14, 2026Fluid/Blood Leak
DURING AORTIC SURGERY WITH VASCUTEK GELWEAVE 4 BRANCH PLEXUS 26 MM THERE WAS BLEEDING AROUND THE GRAFT. PATIENT OUTCOME IS UNKNOWN AT THIS TIME
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24066640 ↗MalfunctionMay 28, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
GELWEAVE STRAIGHT RECEIVED BY CUSTOMER WITH LABELS MISSING FROM INSIDE CARTON.( ONLY ONE WAS IN THERE RATHER THAN THE NORMAL X 4 STICKERS) GRAFT WAS IMPLANTED WITH NO ISSUES, THE ONE LABEL PRESENT WAS USED. HOSPITALS USE THE SPARE STICKERS PROVIDED ON DOCUMENTATION AS NEEDED, BUT IN THIS CASE, THEY ONLY HAD ONE. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00055 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0249.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22094860 ↗InjuryMay 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
EVENT WAS REPORTED ON 10 APR 2025. THE EVENT WAS REPORTED AFTER CLINICIAN PERFORMED A REVIEW OF PREVIOUS CASES. FOLLOWING DAY 1-2 OF IMPLANTATION, THE PATIENT WITH THE IMPLANTED DEVICE WAS REPORTED WITH A FEVER TO 101.8 OR HIGHER AND LEUCOCYTOSIS TO 20'S. NO NEGATIVE PATIENT OUTCOME OTHER THAN THE SYMPTOMS DESCRIBED WERE REPORTED. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00048 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0219.
Patient problems: Fever
MAUDE report 21991932 ↗InjuryMay 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
EVENT WAS REPORTED ON 10 APR 25. THE EVENT WAS REPORTED AFTER CLINICIAN PERFORMED A REVIEW OF PREVIOUS CASES. FOLLOWING DAY 1-2 OF IMPLANTATION, THE PATIENT WITH THE IMPLANTED DEVICE WAS REPORTED WITH A FEVER TO 101.8 OR HIGHER AND LEUCOCYTOSIS TO 20'S. NO NEGATIVE PATIENT OUTCOME OTHER THAN THE SYMPTOMS DESCRIBED WERE REPORTED.
Patient problems: Fever
MAUDE report 21991926 ↗InjuryMay 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
EVENT WAS REPORTED ON 10 APR 2025. THE EVENT WAS REPORTED AFTER CLINICIAN PERFORMED A REVIEW OF PREVIOUS CASES. FOLLOWING DAY 1-2 OF IMPLANTATION, THE PATIENT WITH THE IMPLANTED DEVICE WAS REPORTED WITH A FEVER TO 101.8 OR HIGHER AND LEUCOCYTOSIS TO 20'S. NO NEGATIVE PATIENT OUTCOME OTHER THAN THE SYMPTOMS DESCRIBED WERE REPORTED. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00046 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0217.
Patient problems: Fever
MAUDE report 21991894 ↗InjuryMay 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
EVENT WAS REPORTED ON 10 APR 25. THE EVENT WAS REPORTED AFTER CLINICIAN PERFORMED A REVIEW OF PREVIOUS CASES. FOLLOWING DAY 1-2 OF IMPLANTATION, THE PATIENT WITH THE IMPLANTED DEVICE WAS REPORTED WITH A FEVER TO 101.8 OR HIGHER AND LEUCOCYTOSIS TO 20'S. NO NEGATIVE PATIENT OUTCOME OTHER THAN THE SYMPTOMS DESCRIBED WERE REPORTED.
Patient problems: Fever
MAUDE report 21991892 ↗InjuryMay 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
EVENT WAS REPORTED ON (B)(6) 2025. THE EVENT WAS REPORTED AFTER CLINICIAN PERFORMED A REVIEW OF PREVIOUS CASES. FOLLOWING DAY 1-2 OF IMPLANTATION, THE PATIENT WITH THE IMPLANTED DEVICE WAS REPORTED WITH A FEVER TO 101.8 OR HIGHER AND LEUCOCYTOSIS TO 20'S. NO NEGATIVE PATIENT OUTCOME OTHER THAN THE SYMPTOMS DESCRIBED WERE REPORTED.
Patient problems: Fever
MAUDE report 21991874 ↗InjuryMay 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
EVENT WAS REPORTED ON 10 APR 2025. THE EVENT WAS REPORTED AFTER CLINICIAN PERFORMED A REVIEW OF PREVIOUS CASES. FOLLOWING DAY 1-2 OF IMPLANTATION, THE PATIENT WITH THE IMPLANTED DEVICE WAS REPORTED WITH A FEVER TO 101.8 OR HIGHER AND LEUCOCYTOSIS TO 20'S. NO NEGATIVE PATIENT OUTCOME OTHER THAN THE SYMPTOMS DESCRIBED WERE REPORTED. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00042 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0213.
Patient problems: Fever
MAUDE report 21991864 ↗MalfunctionMar 25, 2025Fluid/Blood Leak; Off-Label Use; Fluid/Blood Leak; Off-Label Use
A 7-YEAR-OLD CHILD WAS TREATED FOR IMPLANTATION OF A BERLIN HEART DUE TO RHYTHMIC DILATED HEART DISEASE ON THE (B)(6) 2025. IMPLANTATION OF THE DEVICE TOOK PLACE WITH THE NEED TO INSTALL A 12 MM DIAMETER DACRON (GELWEAVE STRAIGHT DEVICE) PROSTHESIS. A HEMOSTATIC RECOVERY WAS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, ABNORMAL BLOOD OOZING WAS OBSERVED FROM THE PROSTHESIS TISSUE. THE SURGEON REINFORCED THIS TISSUE BY APPLYING A SPRAY OF "COSEAL" BIOLOGICAL GLUE TO ENSURE THE WATERTIGHTNESS OF THE SYSTEM. THE OOZING OBSERVED WAS GENERALIZED OVER THE ENTIRE PROSTHESIS AND WAS NOT LIMITED TO THE SUTURE AREAS. SURGICAL REVISION/ INTERVENTION WAS REQUIRED. THE HEART TRANSPLANT WAS CARRIED OUT LATER. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00032 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21686515 ↗
Other Vascutek Ltd products
All Vascutek Ltd devices →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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