Gelsoft™ 631809DBRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05037881110011), received between Feb 15, 2017 and Jul 26, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K162803, K990503); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2022Material Integrity Problem; Material Integrity Problem

  ON (B)(6) A PATIENT HAD A GELSOFT DOUBLE BIFURCATE DEVICE IMPLANTED. IN AN UNCONFIRMED DAY IN MAY 22 THE PATIENT ATTENDED A FOLLOW UP EXAMINATION WHERE IT WAS DETECTED THAT THE GELSOFT DEVICE WAS LEAKING WITHIN THE RIGHT EXTERNAL ILIAC. ON (B)(6) AN INTERVENTION WAS PERFORMED WHEREBY A GORE MANUFACTURED EXCLUDER DEVICE WAS IMPLANTED TO ARREST THE BLEEDING. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT SUFFERED NO REPORTED DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102475 ↗
• MalfunctionMar 12, 2021Material Integrity Problem; Material Integrity Problem

  VASCUTEK LTD.S (B)(4) DISTRIBUTION PARTNER ((B)(4)) REPORTED AN INCIDENCE OF BLOOD LEAKAGE OF A GELSOFT BIFURCATE GRAFT. THE GRAFT WAS ORIGINALLY IMPLANTED ON (B)(6) 2019. THE PATIENT UNDERWENT A LAPAROTOMY PROCEDURE ON (B)(6) 2021 FOR THE REMOVAL OF A PSEUDO ANEURYSM; IT WAS NOTED AFTER THE REMOVAL OF THE ANEURYSM BLOOD LEAKAGE WAS OBSERVED FROM THE IN-SITU GELSOFT GRAFT. THE EVENT WAS REPORTED TO VASCUTEK LTD. AS POSSIBLY DEVICE RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11471915 ↗
• MalfunctionJan 6, 2021Material Puncture/Hole; Material Perforation; Material Integrity Problem; Material Puncture/Hole; Material Perforation; Material Integrity Problem

  BLOOD LEAKAGE: AFTER THE PROXIMAL PART WAS ANASTOMOSED, BLOOD LEAKAGE OCCURRED AT A PINHOLE ON THE JOINT SURFACE BETWEEN THE GRAFT BODY AND THE SIDE BRANCH. WHEN THE RENAL ARTERY WAS RECONSTRUCTED, THE GRAFT WAS CLAMPED USING GRAFT-CLAMPING FORCEPS WITH A SOFT NELATON COVER. THEN, THREE PINHOLES WERE FOUND AND BLOOD LEAKAGE WAS NOTED. SINCE THE PROXIMAL SIDE HAD ALREADY BEEN SUTURED, IT WAS IMPOSSIBLE TO REPLACE THE GRAFT WITH ANOTHER ONE. AS HEMOSTASIS WAS NOT ACHIEVED BY MANUAL COMPRESSION ONLY, A 5-0 SUTURE WAS USED FOR SUTURE AND HEMOSTASIS. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. NO HEALTH DAMAGE TO THE PATIENT HAS BEEN REPORTED. THE SURGEON USED THE GRAFT AS USUAL. BLOOD LEAKED JUST BY PICKING THE PART UP WITH A PAIR OF TWEEZERS. THE CAUSE OF THIS EVENT IS UNKNOWN, BUT THERE IS A POSSIBILITY THAT THE DEVICE ITSELF MIGHT HAVE A PROBLEM. OPERATION TYPE: THORACOABDOMINAL VASCULAR PROSTHESIS REPLACEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11122394 ↗
• MalfunctionSep 23, 2019Material Integrity Problem; Material Integrity Problem

  DURING THE IMPLANTATION SURGERY OF A GELSOFT DOUBLE BIFURCATE THAT OCCURRED ON (B)(6) 2019. THE CLINICIAN REPORTED THAT THE GRAFT LEAKED IN TWO LOCATIONS (BIFURCATION AND THE ROOT OF A BRANCH). THE LEAKAGE WAS ARRESTED BY SUTURING THESE LOCATIONS. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER COMPLICATIONS.

  Patient problems: Blood Loss

  MAUDE report 9102459 ↗
• MalfunctionFeb 15, 2017Leak/Splash; Device Operational Issue; Leak/Splash; Device Operational Issue

  IT WAS REPORTED THAT WHEN BLOOD FLOWED AFTER THE GRAFT WAS ANASTOMOSED, THERE WAS LEAKAGE FROM A POINT IN EACH OF THE GRAFT LIMBS (TWO POINTS IN TOTAL). ONE LEAKAGE WAS STOPPED BY PRESSING WITH FINGERS. THE OTHER LEAKAGE WAS STOPPED BY APPLYING A STITCH. NOTHING WAS PERFORMED IN THE BRANCH PARTS UNTIL THE LEAKAGE WAS FOUND. A CLAMP OR OTHER APPLIANCES WITH A SHARP POINT WAS NOT USED. WHEN THE PROCEDURE WAS COMPLETED, THERE WAS NO BLOOD LEAKAGE. THERE WAS NO PATIENT CONSEQUENCE AS A RESULT OF THE EVENT. IT WAS CONFIRMED THAT A SIZE 4-0 PROLENE NEEDLE WAS USED AND THAT THE GRAFT WAS NOT SOAKED IN SALINE PRIOR TO USE, BUT SALINE WAS SPRAYED OVER THE GRAFT WITH A SYRINGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6331089 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162803, K990503. One submission often covers many models, so check the product and lot details in each record.

• Z-0336-2014 · Oct 23, 2013 · Terminated
  Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diame