Gelsoft Plus™ 631809PRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05037881115535), received between May 18, 2018 and Nov 14, 2024 — classified as 1 injury, 3 malfunctions.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 11, 2019Material Integrity Problem; Material Integrity Problem

  AFTER THE GRAFT WAS ANASTOMOSED (PROXIMAL END) TWO (2) HOLES WERE IDENTIFIED (ONE IN THE BODY AND ONE IN THE RIGHT LEG). THE SURGEONS DECIDED TO KEEP THE GRAFT IN PLACE AND SUTURED THE HOLES.

  Patient problems: Blood Loss

  MAUDE report 8779542 ↗
• InjuryMay 18, 2018Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  VASCUTEK LTD. WAS NOTIFIED OF AN EVENT THAT OCCURRED IN (B)(6), THE EVENT WAS DESCRIBED AS FOLLOWS: BIFURCATED GRAFT IMPLANTED (B)(6) 2017 FOR AAA. TYPICAL POSTOP SURVEILLANCE WAS NORMAL. BLOOD LOSS IN FIRST CASE DOCUMENTED AT 1500ML. PATIENT PRESENTED AT HOSPITAL ON (B)(6) 2018 WITH A FRANK INTRAPERITONEAL AAA RUPTURE DESPITE HIS PRIOR REPAIR. ON EXPLORATION, THERE WAS A 3-4MM HOLE IN THE LIMB WHICH HAD TO BE REPAIRED. CLEARLY FAR TOO BIG TO BE A MISSED HOLE IN THE GRAFT AT TIME OF IMPLANT (THE BLEEDING WAS PRETTY CATASTROPHIC). SURGEON THAT COMPLETED REPAIR NOTED "A TREMENDOUS AMOUNT OF BLOOD WAS EVACUATED FROM THE PERITONEAL CAVITY WITH LOTS OF CLOTS AND LOTS OF BLOOD, LOTS OF FLUID WAS REMOVED." THE ANAESTHETIST DOCUMENTED THAT BLOOD LOSS WAS CHALLENGING TO DISCERN DUE TO THE NUMBER OF BLOOD CLOTS. HOLE WAS NOT LOCATED WITHIN THE FIRST CENTIMETRE PAST THE CROTCH, SO NOT CONSISTENT WITH A CLAMP INJURY LOCATION. NO CALCIFICATIONS ON THE SURROUNDING AORTIC SAC THAT COULD HAVE ERODED THE GRAFT. GRAFT WAS STRAIGHT SO NOT AT A FLEXION POINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7524966 ↗

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