Gelsoft PlusRecalls & reported problems across all models
Vascutek Ltd · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 53
- Deaths reported
- 2
- Injuries reported
- 15
- Recalls
- 0
We found 19 models of Gelsoft Plus by Vascutek Ltd in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Oct 21, 2016 and Jul 20, 2026 — classified as 2 deaths, 15 injuries, 36 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (15 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 Gelsoft Plus problems
Device problems
- Material Integrity Problem15
- Material Puncture/Hole14
- Leak/Splash8
- Material Perforation6
- Adverse Event Without Identified Device or Use Problem5
- Off-Label Use5
- Hole In Material4
- Device Operates Differently Than Expected3
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Hemorrhage/Blood Loss/Bleeding7
- No Known Impact Or Consequence To Patient6
- Blood Loss5
- No Consequences Or Impact To Patient5
- No Information4
- Seroma3
- Obstruction/Occlusion2
Gelsoft Plus models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Gelsoft Plus™ 631608PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER10 reports
- Gelsoft Plus™ 636008PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER8 reports
- Gelsoft Plus™ 631407PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER8 reports
- Gelsoft Plus™ 631809PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER4 reports
- Gelsoft Plus™ 632010PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 death4 reports
- Gelsoft Plus™ 633008PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER3 reports
- Gelsoft Plus™ 636006PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- Gelsoft Plus™ 633006PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- Gelsoft Plus™ 633010PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 death2 reports
- Gelsoft Plus™ 636007PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelsoft Plus™ 634006PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelsoft Plus™ 634008PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelsoft Plus™ 633014PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelsoft Plus™ 632520PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelsoft Plus™ 631508PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelsoft Plus™ 631516PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelsoft Plus™ 631206PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelsoft Plus™ 632412PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- Gelsoft Plus™ 690808PPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
Recent Gelsoft Plus adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2026Material Integrity Problem
Gelsoft Plus Bifurcate being implanted in a 44 year old male patient at (b)(6). A medial approach to the arm was made along the vascular pathway. Dissection was performed through layers until the brachial vein and superficial cutaneous brachial nerve were identified. Dissection of the deep layer was then performed, identifying the median nerve, brachial artery, and vein. The dissection extended into the axillary region, revealing no lesions at this level. Dissection continued distally, identifying the findings described 2 cm above the antecubital fossa. The proximal and distal edges of the brachial artery were reshaped. The brachial vein was ligated. A Fogarty suture No. 3-4-5 was passed proximally and distally, obtaining a single, fresh blood clot. The proximal and distal areas were irrigated with heparinized saline solution. A 6mm Dacron graft was placed with a proximal double-pillar anastomosis. Upon verifying the adequate seal of the anastomosis, it was confirmed that Hemorrhagic leakage was identified throughout the graft, so it was decided to remove it.No harm to the patient was noted , however it was considered a serious adverse event due to the increased surgery time.This r
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25869386 ↗InjuryJul 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
EVENT WAS REPORTED AS PART OF THE PANTHER POST MARKET STUDY. (B)(6). PATIENT TREATED WITH GELSOFT PLUS (STRAIGHT) FOR AORTO-ILIAC OCCLUSION IN (B)(6) 2023. ON (B)(6) 2025 THE PATIENT ATTENDED A FOLLOW UP VISIT TO THE HOSPITAL AND FLUID ACCUMULATION AROUND THE BYPASS WAS DETECTED. THIS WAS PREVIOUSLY INDICATED IN A CT-ANGIOGRAM ON (B)(6) 2025. BLOOD SAMPLES SHOWED NO SIGNS OF INFLAMMATION/INFECTION. A DIAGNOSTIC PUNCTURE OF THE FLUID WAS CONDUCTED. THE MICROBIOLOGICAL SAMPLES SHOWED NO BACTERIAL/FUNGAL GROWTH. THE EVENT IS ONGOING.
Patient problems: Seroma
MAUDE report 22468406 ↗InjuryJun 20, 2025Fluid/Blood Leak; Off-Label Use; Fluid/Blood Leak; Off-Label Use
DURING THE DEVICE INSERTION PROCEDURE, EXCESSIVE BLOOD LOSS WAS OBSERVED. THE DEVICE APPEARED TO HAVE POROSITY, WHICH ALLOWED BLOOD TO LEAK, RESULTING IN AN ESTIMATED LOSS OF APPROXIMATELY 6 LITRES. THIS PROCEDURE WAS EXECUTING FOLLOWING THE REGULAR PROTOCOL ESTABLISHED FOR THESE TYPES OF INTERVENTIONS. A SECOND SURGICAL PROCEDURE WAS REQUIRED. PATIENT OUTCOME: UNKNOWN.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22296113 ↗MalfunctionMay 26, 2025Material Puncture/Hole; Material Puncture/Hole
EVENT WAS REPORTED ON 30 APR 25, THIS WAS FOR LEAKAGE OF GELSOFT PLUS DEVICE. AFTER PERFORMING THE ANASTOMOSIS OF THE VASCULAR PROSTHESIS IN THE PROXIMAL REGION, WHEN REMOVING THE CLAMP TO VERIFY LEAKAGE AND THE ANASTOMOSIS INTEGRITY THEY OBSERVED A BLOOD LEAKAGE THROUGH TWO HOLES LOCATED IN THE MIDDLE PORTION OF THE VASCULAR GRAFT. THIS FAILURE CAUSED A DELAY IN THE PROCEDURE CONTINUITY AS THEY NEEDED TO REQUEST SUTURE TO SEAL THE GRAFT WHILE THEY SOLVE THE SITUATION. FINALLY, THE PHYSICIAN DECIDED TO USE THE SAME GRAFT AND SEAL IT WITH HEMOSTATIC AGENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22083183 ↗InjuryJan 21, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
EVENT DATE: (B)(6) 2024. IMPLANT DATE: (B)(6) 2024. THE PATIENT UNDERWENT VASCULAR GRAFT REPLACEMENT TO TREAT AN ABDOMINAL AORTIC ANEURYSM. AFTER ANASTOMOSIS OF THE PROXIMAL PORTION, BLOOD LEAKAGE OCCURRED FROM THE Y-GRAFT BIFURCATION. THE DAMAGED SITE WAS THEN REPAIRED ON SITE, AND THE SURGERY WAS CONTINUED. SUBSEQUENTLY, THE SURGERY WAS SUCCESSFULLY COMPLETED. OPERATION TYPE: VASCULAR GRAFT REPLACEMENT FOR ABDOMINAL AORTIC ANEURYSM BLOOD LOSS: UNKNOWN THIS REPORT IS BEING SUBMITTED AS AN INITIAL- FINAL TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0075.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21197631 ↗MalfunctionNov 14, 2024Material Puncture/Hole; Material Puncture/Hole
DURING SURGERY ON (B)(6) 2024, THE SURGEON UNCLAMPED THE RIGHT ILIAC AFTER COMPLETING ANASTAMOSIS AND STATED THAT THE GRAFT HAD 3 HOLES IN IT. THE SURGEON REPAIRED ALL 3 HOLES AND USED THE PRODUCT . NO PATIENT INJURY AND NO SURGICAL INTERVENTION AS REPORTED BY THE SURGEON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20681858 ↗MalfunctionNov 11, 2024Off-Label Use; Off-Label Use
EVENT DATE: 19 OCT 24, IMPLANT DATE: ON (B)(6) 2024. EVENT WAS REPORTED AS WEAVING DEFECTS. THE SURGICAL GRAFT WAS USED AS A CIRCULATION LINE FOR AORTIC REPLACEMENT PROCEDURE, AND AFTER CLAMP RELEASED, SURGEON FOUND BLOOD EJECT FROM THE SURFACE OF SURGICAL GRAFT (NOT THE ANASTOMOSIS SITE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20651871 ↗MalfunctionNov 11, 2024Off-Label Use; Off-Label Use
EVENT DATE: ON 16 OCT 2024. IMPLANT DATE: ON (B)(6) 2024. EVENT WAS REPORTED AS WEAVING DEFECTS. THE SURGICAL GRAFT WAS USED AS A CIRCULATION LINE FOR AORTIC REPLACEMENT PROCEDURE, AND AFTER CLAMP RELEASED, SURGEON FOUND BLOOD EJECT FROM THE SURFACE OF SURGICAL GRAFT (NOT THE ANASTOMOSIS SITE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20650845 ↗MalfunctionSep 24, 2024Material Puncture/Hole; Material Puncture/Hole
EVENT DATE: 28 AUG 2024. IMPLANT DATE: ON (B)(6) 2024. DURING THE SURGERY, THE DOCTOR FINISHED SUTURE AND FOUND A HOLE IN THE PRODUCT. AND THEY FOUND BLOOD FLOWING IN THE PRODUCT. THERE WAS NO INJURY OR DEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20291296 ↗MalfunctionJul 16, 2024Off-Label Use; Off-Label Use
EVENT REPORTED ON (B)(6) 2024. IMPLANT DATE: (B)(6) 2024, EXPLANT DATE: (B)(6) 2024. AS REPORTED: THE SURGICAL GRAFT WAS USED AS A CIRCULATION LINE FOR AORTIC REPLACEMENT PROCEDURE, AND AFTER CLAMP RELEASED, SURGEON FOUND BLOOD SEEPAGE FROM THE SURFACE OF SURGICAL GRAFT (NOT THE ANASTOMOSIS SITE). EVENT WAS MARKED AS DEVICE RELATED BY THE SITE (DUE TO POSSIBLE WEAVING DEFECTS OR GELATINE FAIL) PATIENT RELEVANT MEDICAL CONDITIONS / PATIENT'S DIAGNOSIS: DAA AORTIC REPLACEMENT SURGERY, (REQUESTED CLARIFICATION OF DAA FROM THE REPORTING SITE). THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP 1 FOR MANUFACTURING REPORT #9612515-2024-00049 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19749536 ↗MalfunctionJul 2, 2024Material Integrity Problem; Material Integrity Problem
THE SURGICAL GRAFT WAS USED AS A CIRCULATION LINE FOR MV MITRAL VALVE REPAIR PROCEDURE, AND AFTER CLAMP RELEASED, SURGEON FOUND BLOOD LEAKAGE FROM THE SURFACE OF SURGICAL GRAFT (NOT THE ANASTOMOSIS SITE). THE PROBLEM OF BLOOD LEAKAGE FROM THE SURFACE OF SURGICAL GRAFT, SURGEON HAS SUTURED THE BLEEDING HOLE TO STOP THE LEAKAGE. THE PATIENT IS STABLE. EVENT REPORTED AS DEVICE RELATED & POSSIBLY PROCEDURE / PRE-EXISTING CONDITION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19655886 ↗MalfunctionJun 27, 2024Material Puncture/Hole; Material Puncture/Hole
DURING AN AXILLO-FEMORAL BYPASS, THE BIFURICATED GRAFT LOT 2003294573 WAS USED. THE SURGEON NOTED THAT THERE WAS A PREEXISTINGHOLE IN THE BIFURICATED GRAFT WHICH WAS DISCOVERED DURING SURGERY. THE PATIENT EXPERIENCED BLOOD LOSS WHEN THE GRAFT WAS IN SITU, AT WHICH POINT THE HOLE WAS FOUND TO BE IN THE BIFURICATE GRAFT. THE GRAFT REMAINED IMPLANTED AND THE HOLE REPAIRED WITH A PATCH OF UNUSED GRAFT MATERIAL. THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP #1 FOR MFG REPORT NUMBER 9612515-2024-00044 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19622512 ↗InjuryJun 18, 2024Obstruction of Flow; Obstruction of Flow
CLINICAL TRIAL: (B)(4) , SITE NO. (B)(4), PATIENT NO.: (B)(6) , IMPLANT DATE: ON (B)(6) 2019 EVENT DATE: 21 APR 24 EVENT: OCCLUSION. RELEVANT MEDICAL HISTORY OF INDICATION FOR SURGERY WAS AORTO-FEMORAL OCCLUSIVE DISEASE (SUBTYPE: ULCERATION). OCCLUSION OF THE ILIACOFEMORAL AXIS AND LEFT BRANCH OF THE AORTOBIFEMORAL BYPASS WITH NON-VIABLE ACUTE LIMB ISCHEMIA OF THE LEFT LEG. ACTION TAKEN BY THE CLINICIANS: REINTERVENTION OF EMBOLECTOMY ILIACOFEMORAL AORTA GRAFT LEFT AND PERCUTANEOUS ANGIOPLASTY + STENTING ON (B)(6) 2024. PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2024 AND DISCHARGED ON (B)(6) 2024. PATIENT OUTCOME: RECOVERED, RESOLVED WITHOUT SEQUELAE. REPORTED BY THE CLINICIANS AS POSSIBLY DEVICE FAILURE/ DEFICIENCY/ PROCEDURE AND PRE-EXISTING CONDITION.
Patient problems: Ischemia; Obstruction/Occlusion
MAUDE report 19555740 ↗DeathMay 29, 2024Misconnection; Misconnection
EVENT REPORTED BY EMAIL FROM CARDIOTHORACIC BUSINESS MANAGER ON 02 MAY 24 GELSOFT PLUS STRAIGHT GRAFT IMPLANTED IN (B)(6) HOSPITAL WAS LEAKING THROUGH THE GRAFT , NOT AT THE ENDS. GRAFT WAS SUCCESSFULLY IMPLANTED. EVENT INTAKE FORM WAS RECEIVED ON 08 MAY 24 10MM GRAFT WAS BEING USED FOR CANNULATION AND WAS NOT IMPLANTED HOWEVER IT HAS BEEN DISGARDED AND IS NO LONGER AVAILABE TO BE RETURNED. PATIENT PRE-CONDITION WAS ENTERED AS POSTOP VSD - VENTRICULAR SEPTAL DEFECT. POOR LEFT VENTRICULAR AND RIGHT VENTRICULAR FAILURE PREPARATION FOR ECMO ,THE PATIENT HAS SINCE PASSED AWAY, CLINICIAN STATED " THE CONDUIT ISSUE IS NOT A CAUSE OF DEATH". AS PER EVENT INTAKE FORM THIS WAS NOT RELATED TO A DEVICE FAILURE/ DEFICIENCY. THIS REPORT IS BEING SUBMITTED TO PROVIDE INITIAL - FINAL EVENT INFORMATION FOR MANUFACTURING REPORT #0612515-2024-00032 COMPLAINT (B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19414780 ↗InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
AS REPORTED PANTHER STUDY: EVENT REPORTED AS "POSSIBLY RELATED TO DEVICE" BUT NO DEVICE DEFICIENCY REPORTED, AORTA-DUODENAL FISTULA WITH HEMATEMESIS IN 2022. NOTE: SUBJECT HAD TELEPHONE FOLLOW UP FOR 5 YEAR FOLLOW UP VISIT - THIS IS WHEN THIS ADVERSE EVENT WAS DISCOVERED BY SITE. SUBJECT WAS TREATED AT DIFFERENT HOSPITALS FOR BOTH THE ENDOVASCULAR AND OPEN SURGICAL REPAIR AND THE STUDY SITE DO NOT HAVE FURTHER INFORMATION AT THIS TIME. SURGICAL INTERVENTION: ENDOVASCULAR REINTERVENTON BY STENT IN 2022, AND OPEN REPAIR AT A LATER DATE IN (B)(6) 2023 (TUBE PROSTHESIS -> BIFURCATED PROSTHESIS). TWO SEPARATE REINTERVENTIONS.
Patient problems: Hematemesis
MAUDE report 19010379 ↗
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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