Gelsoft Plus™ 636008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05037881115047), received between Dec 13, 2016 and Jul 10, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K162803, K955230); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  EVENT REPORTED VIA THE (B)(6) STUDY ON (B)(6) 2021. EVENT REPORTED AS "THROMBOSIS OF THE PATIENTS SUBTICULAR FEMORAL POPLITEAL BYPASS ON THE RIGHT". PATIENT WAS ADMITTED ON (B)(6) 2021 & A THROMBECTOMY PROCEDURE WAS PERFORMED PATIENT WAS DISCHARGED ON (B)(6) 2021. EVENT REPORTED AS POSSIBLY DEVICE RELATED ISSUE RESOLVED WITHOUT SEQUELAE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12950082 ↗
• MalfunctionJul 25, 2019Material Integrity Problem; Material Integrity Problem

  VASCUTEK LTD. WAS NOTIFIED OF AN EVENT THAT OCCURRED IN (B)(6), THE EVENT WAS DESCRIBED AS FOLLOWS: GRAFT DOES NOT HAVE VASCULAR PERMEABILITY, THIS WAS CAUSING OUTFLOW OF BLOOD AFTER UNCLAMPING THE ARTERY, CAUSING EXUDATION (OOZING).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8826136 ↗
• MalfunctionAug 24, 2018Leak/Splash; Leak/Splash

  VASCUTEK LTD. WAS NOTIFIED OF AN EVENT THAT OCCURRED IN (B)(6), THE EVENT WAS DESCRIBED AS FOLLOWS: DURING FEMORO-POPLITEAL BYPASS SURGERY, THE PROSTHESIS GELSOFT PLUS PRESENTED MANY DEFECTS ONCE IT WAS IN LOAD (AFTER COMPLETION OF A PROXIMAL ANASTOMOSIS). MANY SMALL HOLES HAVE BEEN SEEN ALL ALONG THE GRAFT, INDUCING MASSIVE BLOOD LOSS GREATER THAN 900CC FOR THE PATIENT, FILLING MADE WITH 1250CC OF CRYSTALLOID AND 2 PELLETS OF GR FOR TRANSFUSION. PATIENT IS DOING WELL. THERE WAS NO POST-OPERATIVE LEAKAGE OBSERVED.

  Patient problems: Blood Loss

  MAUDE report 7812309 ↗
• InjuryMay 18, 2018Device Operates Differently Than Expected; Material Deformation; Device Operates Differently Than Expected; Material Deformation

  VASCUTEK LTD. WAS NOTIFIED OF AN EVENT THAT OCCURRED IN (B)(6), THE EVENT WAS DESCRIBED AS FOLLOWS: GELSOFT PLUS TM STRAIGHT GRAFT WAS USED FOR CAROTID BYPASS. THE GRAFT BECAME ELONGATED OVER TIME (1-YEAR PERIOD) TO THE POINT IT WAS BEGINNING TO ERODE THROUGH THE SKIN. AS A RESULT, THE GRAFT WAS REPLACED. THE EXACT DATES OF THE EVENT AND EXPLANT DATE ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7525086 ↗
• InjuryDec 13, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  VASCUTEK LTD. WAS NOTIFIED OF AN EVENT THAT OCCURRED IN (B)(6); THE EVENT WAS DESCRIBED AS FOLLOWS: ON THE (B)(6) 2009, THE PATIENT RECEIVED X2 VASCUTEK LTD. MANUFACTURED GELSOFT PLUS STRAIGHT GRAFTS AS PART OF A VASCULAR SYSTEM REPAIR. POST IMPLANT (6.5 YEARS) LATER THE PATIENT HAD DEVELOPED A SEROMA. ON (B)(6) 2016 (X2) SECTIONS OF ONE OF THE IMPLANTED GRAFTS WERE EXPLANTED AND REPLACED. (THIS WAS RECORDED AS COMP 3175 - FDA REF 9612515-2016-00022). FOLLOWING THIS, ON THE (B)(6) 2016, A THIRD SECTION OF THE GRAFT(S) WAS EXPLANTED DUE TO A SEROMA FORMATION. NO EFFUSION OR INFECTION WAS IDENTIFIED UPON GRAFT EXTRACTION.

  Patient problems: Seroma

  MAUDE report 6168739 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162803, K955230. 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