Gelweave™ 730030ADPRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05037881120133), received between Mar 25, 2021 and Oct 2, 2024 — classified as 1 death, 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K013022, K162794); they may or may not involve this specific model.

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2024Missing Information; Missing Information

  GELWEAVE VALSALVA GRAFT RECEIVED WITH NO IMPLANT STICKERS INSIDE A BRAND NEW IMPLANT BOX..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349898 ↗
• InjurySep 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL STUDY PANTHER (B)(6), SITE NO. 21, PATIENT NO. 012, EVENT OF "ABSCESS" HAS BEEN REPORTED BY THE SITE AS POSSIBLY RELATED TO THE DEVICE AND RELATED TO THE PROCEDURE. PATIENT WITH AN ASCENDING AORTIC ANEURYSM, EXPERIENCED A SERIOUS ADVERSE EVENT OF AORTIC ROOT ABSCESS (POSSIBLE ENDOCARDITIS). THE SUBJECT UNDERWENT AN OPEN SURGICAL REPAIR OF THE ASCENDING AORTA WITH A GELWEAVE VALSALVA DEVICE ON (B)(6) 2022. FOLLOWING THE PROCEDURE THE SITE REPORTED AN EXCELLENT DEVICE ASSESSMENT, WITH NO SUTURE HOLE BLEEDING AND NO GRAFT LEAKAGE, WITH NO COMPLICATIONS DURING THE PROCEDURE. ON POST OPERATIVE DAY 958 (B)(6) 2024), THE SUBJECT EXPERIENCED THE SERIOUS ADVERSE EVENT OF AORTIC ROOT ABSCESS (POSSIBLE ENDOCARDITIS). SITE PROVIDED THE FOLLOWING DESCRIPTION OF THE EVENT: AORTIC ROOT ABSCESS, ENDOCARDITIS: FOLLOWING CT SCAN ON THE (B)(6) 2024, THE RADIOLOGIST NOTED CONCERNS OF ENDOCARDITIS AND REGARDING THE AORTIC ROOT. AFTER SPEAKING WITH THE DOCTOR, THE PATIENT WAS DIRECTLY ADMITTED FOR REINTERVENTION. SURGICAL RE-INTERVENTION WAS REQUIRED: A RE-DO AORTIC ROOT REPLACEMENT/BENTALL PROCEDURE ON (B)(6) 2024. THE VALSALVA GRAFT WAS EXPLANTED. THE EVENT IS CONSIDERED ONGOING AT THIS TIME.

  Patient problems: Abscess; Angina; Aortic Valve Insufficiency/ Regurgitation; Ischemic Heart Disease; Myocardial Infarction; Stroke/CVA

  MAUDE report 20300740 ↗
• InjuryAug 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL TRIAL PANTHER_32 PATIENT NUMBER (B)(6), 40 YEAR OLD MALE PATIENT HAD A RELEVANT MEDICAL CONDITION OF AORTIC VALVE REGURGITATION WITH POSSIBLE DEVICE FAILURE / DEFICIENCY OF SUSPECTED GRAFT LEAKAGE, AND POSSIBLY RELATED TO THE PROCEDURE BUT NOT RELATED TO PRE-EXISTING CONDITION AND SURGICAL INTERVENTION. PATIENT HAD AORTIC BLEEDING. GRAFT LEAKAGE ON MRI TO BE CONFIRMED BY ETT. GRAFT LEAKAGE SEEN IN IMAGING DID NOT LEAD TO A CLINICAL EVENT WITH A NEED FOR REINTERVENTION. NO ACTION WAS TAKEN. NOTE: NO LEAKAGE WAS OBSERVED IN CT SCANS AT PREVIOUS VISIT IN (B)(6) 2019. PATIENT HAS NOT ATTENDED ANY FURTHER FOLLOW UP VISITS. SITE HAVE BEEN CONTACTED TO DETERMINE CURRENT STATUS/ OUTCOME OF PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17478437 ↗
• MalfunctionMay 6, 2022Material Puncture/Hole; Material Puncture/Hole

  ON (B)(6) 2022 A GELWEAVE VALSALVA GRAFT WAS MATED WITH A PERIMOUNT MAGNA EASE 27MM VALVE AND IMPLANTED; BUT BEFORE THE ATTACHMENT OF THE CORONARY BUTTONS, THE CLINICIAN NOTICED THREE SLIT LIKE HOLES ON THE SKIRT OF THE VALSALVA. THE SLITS WERE DESCRIBED AS LOOKING AS IF THEY HAD BEEN CAUSED BY A BLADE, THEY MEASURED APPROX. 5MM IN LENGTH AND APPROX. 1CM APART GOING AROUND THE RV SIDE. ALL THREE SLITS WERE REPAIRED WITH PLEDGETED SUTURES AND SUBSEQUENT TESTING IDENTIFIED NO LEAKS, NO DETRIMENT TO THE PATIENT, NO BLEEDING DUE TO THESE SLITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14302854 ↗
• InjuryNov 3, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  EVENT WAS REPORTED TO VASCUTEK LTD VIA CLINICAL TRIAL AS ALLERGIC REACTION TO GELATIN/POLYESTER. CLINICIAN INDICATED THIS EVENT WAS NOT DEVICE RELATED. (B)(6) 2021 : HYPOTENSION AFTER SURGICAL STERNUM CLOSURE DUE TO VASOPLEGIA CAUSED BY AN ALLERGIC REACTION REPEAT STERNOTOMY FOR VISUAL INSPECTION PERFORMED, TRENDELENBURG POSITION + FEMORAL ARTERIAL CATHETER FOR HEMODYNAMIC CONTROL EVENT RESOLVED ON (B)(6) 2021. (B)(6) 2021 : URTICARIAL RASH RESOLVED WITH MEDICATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12745163 ↗
• DeathMar 25, 2021Patient-Device Incompatibility; Biocompatibility; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Patient-Device Incompatibility; Biocompatibility; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  VASCUTEK LTD. WAS INITIALLY CONTACTED ON (B)(6) 21 BY (B)(6) DISTRIBUTOR OF A REQUEST FROM A HOSPITAL FOR INFORMATION ON PRESERVATION OF AN EXPLANTED GELWEAVE GRAFT FROM A PROCEDURE WHERE THE PATIENT DIED. FURTHER INFORMATION WAS REQUESTED AND ON (B)(6) 2021 FURTHER INFORMATION WAS RECEIVED IN THE FORM OF THE REPORT SUBMITTED BY THE HOSPITAL TO (B)(6) WITH A ROUGH ENGLISH TRANSLATION PROVIDED BY THE DISTRIBUTOR. NO NOTIFICATION OF THE EVENT WAS RECEIVED BY VASCUTEK LTD. PRIOR TO NOTIFICATION TO DISTRIBUTOR BY (B)(6). THE EVENT WAS REPORTED TO (B)(6) AS FOLLOWS: DATE : (B)(6) 2021. BY : MRS (B)(6). FOR GELWEAVE VALSALVA 30 MM DIAM. PATIENT CLINICAL STATUS: DEATH. DEVICE EXPLANTED FOR EXPERTISE. CIRCUMSTANCES / DESCRIPTION OF FACTS: ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED FOR HEART SURGERY FOR AN ASCENDING AORTIC REPLACEMENT AS WELL AS THE AORTIC VALVE. THE PRACTITIONER PERFORMS BENTALL SURGERY AND IMPLANTS: A VALSAVA VASCULAR PROSTHESIS FROM THE SUPPLIER VASCUTEK (B)(6) (REF: 730030ADP, BATCH NUMBER:21513568 - 3559, SERIAL NUMBER: (B)(4)) AND AN INSPIRIS 25 MM BIOLOGICAL AORTIC VALVE FROM THE SUPPLIER EDWARDS (REF: (B)(4), NUMBER OF SERIES: (B)(4)) ON (B)(6) 2021, IN INTENSIVE

  Patient problems: Asystole; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 11567185 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013022, K162794. One submission often covers many models, so check the product and lot details in each record.

• Z-2542-2021 · Jul 8, 2021 · Terminated
  The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Val