Gelsoft Plus™ 631608PRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05037881115528), received between Dec 12, 2016 and Jun 9, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2021Material Puncture/Hole; Material Perforation; Material Integrity Problem; Material Puncture/Hole; Material Perforation; Material Integrity Problem

  REPORTED TO VASCUTEK LTD. AS FOLLOWS: BLOOD LEAKAGE (BRANCH): THE GELSOFT PLUS BIFURCATE WAS USED FOR ABDOMINAL AORTIC REPLACEMENT. HEAVY BLOOD LEAKAGE WAS OBSERVED FROM THE BIFURCATION POINT OF THE GELSOFT. THE LEAKAGE WAS SUTURED WITH A SINGLE STITCH OF A PLEDGET AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. SUBSEQUENTLY THE PROCEDURE WAS COMPLETED SUCCESSFULLY. BLOOD LOSS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11964008 ↗
• MalfunctionNov 26, 2020Material Puncture/Hole; Material Puncture/Hole

  ON (B)(6) 2020 A CLINICIAN IMPLANTED A GELSOFT PLUS BIFURCATE GRAFT. AFTER ANASTOMOSIS BUT BEFORE THE RELEASE OF BLOOD INTO THE GRAFT, A LARGE HOLE (UNDEFINED SIZE) WAS IDENTIFIED AT THE BIFURCATION. THE DEVICE WAS DISCARDED AND A REPLACEMENT UNIT WAS UTILISED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10910660 ↗
• MalfunctionJul 17, 2019Material Puncture/Hole; Material Perforation; Material Integrity Problem; Material Puncture/Hole; Material Perforation; Material Integrity Problem

  EVENT WAS REPORTED TO VASCUTEK LTD. AS FOLLOWS: AFTER THE IMPLANT WAS ANASTOMOSED (PROXIMAL), THE SURGEON NOTICED ONE (1) HOLE IN THE GRAFT (AT THE BIFURCATION LEVEL). THE SURGEON DECIDED TO KEEP THE GRAFT IN PLACE AND SUTURE THE HOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8797150 ↗
• MalfunctionMay 22, 2019Material Puncture/Hole; Material Perforation; Material Integrity Problem; Material Puncture/Hole; Material Perforation; Material Integrity Problem

  EVENT WAS REPORTED TO VASCUTEK (B)(4) BY VASCUTEK (B)(4) WHO RECEIVED NOTIFICATION OF AN EVENT THAT HAD BEEN SUBMITTED TO (B)(6) AND HAD REQUESTED FURTHER INFORMATION ON EVENT. THE EVENT WAS REPORTED AS FOLLOWS: PATIENT TREATED FOR A AAA ON (B)(6) 2019. LEAKAGE ON RIGHT GRAFT LEG DURING DEBUBBLING FROM 3 SMALL HOLES. LEAKAGE STOPPED WITH NATURAL HEMOSTASIS. PATIENT HOSPITAL STAY ENDED (B)(6). THE ONLY INFORMATION RECEIVED WAS FROM INITIAL REPORT AND INFORMATION REQUEST FROM (B)(6) - NO REPORT OF EVENT WAS RECEIVED DIRECTLY BY VASCUTEK (B)(4) OR VASCUTEK (B)(4) FROM HOSPITAL OR COMPLAINANT.

  Patient problems: No Information

  MAUDE report 8631181 ↗
• MalfunctionApr 18, 2019Material Integrity Problem; Material Integrity Problem

  VASCUTEK LTD RECEIVED A NOTIFICATION FROM OUR (B)(4) DISTRIBUTOR, WHO REPORTED THAT DURING THE IMPLANT OF A GELSOFT PLUS BIFURCATE VASCULAR GRAFT, LEAKAGE WAS REPORTED FROM THE PROXIMAL END OF THE LEFT LIMB OF THE DEVICE. THE LEAKAGE WAS ARRESTED USING LOCALISED MANUAL PRESSURE AND THE APPLICATION OF TACOSEAL TO THE AFFECTED SITE. THE PROCEDURE WAS ELECTIVE AND WAS DEEMED AS SUCCESSFUL WITH NO ADDITIONAL SURGICAL TIME REQUIRED.

  Patient problems: Blood Loss

  MAUDE report 8526321 ↗
• MalfunctionDec 7, 2018Leak/Splash; Leak/Splash

  VASCUTEK LTD. WAS NOTIFIED OF AN EVENT THAT OCCURRED IN USA, THE EVENT WAS DESCRIBED AS FOLLOWS: GRAFT WAS LEAKING AT THE POINT OF BIFURCATION AFTER BEING IMPLANTED. LEAK OCCURRED DURING CARDIOPULMONARY BYPASS.

  Patient problems: Blood Loss

  MAUDE report 8141128 ↗
• MalfunctionOct 18, 2018Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  VASCUTEK LTD. WAS NOTIFIED OF AN EVENT THAT OCCURRED IN (B)(6), THE EVENT WAS DESCRIBED AS FOLLOWS: THE PROSTHESIS AFTER BEING IMPLANTED IN THE PATIENT SHOWED A TEAR IN THE UNION OF BIFURCATION. DURING SURGERY THE GRAFT PRESENTS BLOOD LEAK WITH A SLIGHT NARROW AND UNUSUAL JET, THE SURGEON PROCEEDS TO SUTURE THE TEAR AND SOLVES THE EVENT, LEAVING THE PROSTHESIS IN THE PATIENT.

  Patient problems: Blood Loss

  MAUDE report 7977048 ↗
• MalfunctionMar 15, 2018Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  SURGEON REPORTED THAT THE GRAFT WAS LEAKING FROM SEVERAL PLACES AT BIFURCATION. SURGEON SUGGESTED THAT SOME STITCHING WAS MISSING AT BIFURCATION AREA. ALSO, SURGEON SUGGESTED THAT ONE LEG LOOKED ODD. THERE WERE TWO TO THREE ROUND SPOTS WHERE SURFACE WAS MISSING. GRAFT STARTED LEAKING WHEN THE SURGEON OPENED THE CLAMP. THE DEFECTIVE PART OF THE GRAFT (BIFURCATION AND LEGS) WAS CUT OFF, BIFURCATION AND LEGS FROM ANOTHER GRAFT (BBRAUN UNIGRAFT) WERE ATTACHED TO THE BODY OF THE AFFECTED GRAFT. THE BLOOD LOSS WAS MINIMAL (LESS THAN 10ML) AS THE LEAK WAS NOTICED IMMEDIATELY AND CONTROLLED ON TIME. THERE WAS NO HARM CAUSED TO THE PATIENT, FOR EXAMPLE, PATIENT DID NOT EXPERIENCE HITT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7340803 ↗
• MalfunctionNov 9, 2017Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  THE EVENT WAS REPORTED AS LEAKING PROSTHESIS FROM SEVERAL SMALL HOLES IN THE MATERIAL AROUND THE BIFURCATION AREA. LEAKING WAS NOT IN THE AREA OF THE SUTURE HOLES BUT FROM SPOTS, THAT HAD NOT BEEN NEAR ANY NEEDLE STICK. TACHOSIL WAS USED TO STOP THE BLEEDING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7013961 ↗
• MalfunctionDec 12, 2016Hole In Material; Hole In Material

  THE EVENT WAS DESCRIBED TO VASCUTEK AS; WHEN THE CLAMP WAS RELEASED, BLOOD LEAKED FROM THE GRAFT LEG ON THE DISTAL SIDE 1 TO 2 CM FROM THE BRANCH. TWO BLEEDING POINTS OF NEEDLE HOLE SIZE WERE FOUND AND SUTURES WERE APPLIED.

  Patient problems: No Information

  MAUDE report 6165663 ↗

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