Gelweave™ 73261088/10SARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05037881998459), received between Aug 13, 2024 and Aug 27, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K090987); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Fluid/Blood Leak

  Event was reported as Blood leakage:Redo descending aortic replacement was performed on the patient with ET (Essential Thrombocythaemia) who underwent the Gelweave implantation on (b)(6) 2026. During the procedure, significant blood leakage from the Gelweave was noted. Despite the administration of protamine, there was still significant leakage from the Gelweave, making it difficult to achieve hemostasis. Although nearly two hours passed, hemostasis could not be achieved.Therefore, three SURGIFLO hemostatic matrix kits (Johnson & Johnson) were used, and a SURGICEL absorbable hemostat (Johnson & Johnson) was placed firmly on the bleeding site. Then, the chest was closed. Doctor's comment:Blood leakage occurred from the Gelweave implanted on (b)(6) 2026. Due to the difficulty of achieving homeostasis during the redo procedure because of the leakage, the applicability of Gelweave for patients who will undergo a redo procedure must be considered. It would be difficult to use Gelweave unless the cause of this event is identified because I will not be able to provide patients with reasonable explanations about the devices that will be used during the procedure.There was no health damage

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50470954 ↗
• InjuryJul 1, 2026Fluid/Blood Leak

  EVENT REPORTED AS BLOOD LEAKAGE, AFTER PERFORMING THE DISTAL ANASTOMOSIS, THE DOCTOR CHECKED FOR HEMOSTASIS. HOWEVER, LEAKAGE WAS OBSERVED FROM THE MAIN BODY OF THE GRAFT. THE DOCTOR USED A SURGIFLO (JOHNSON & JOHNSON), A HEMOSTATIC AGENT, TO ADDRESS THE LEAKAGE. HEMOSTASIS WAS ACHIEVED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25677531 ↗
• InjuryAug 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2024, THE SURGERY WAS SUCCESSFULLY COMPLETED WITH VASCULAR GRAFT REPLACEMENT (GELWEAVE 4 BRANCH GRAFT). THE PATIENT WAS THEN DISCHARGED. ON (B)(6) 2024, THE PATIENT UNDERWENT THORACOTOMY FOR SUSPECTED CARDIAC TAMPONADE. OOZING OF SOMETHING SIMILAR TO BLOOD OR SEROMA WAS OBSERVED AROUND THE GELWEAVE VALSALVA GRAFT. HEMOSTATIC SURGERY WAS PERFORMED. OPERATION TYPE: BENTALL, TAR (UNDERSTOOD TO BE TOTAL ARTERIAL REVASCULARIZATION) AND CABG (UNDERSTOOD TO BE CORONARY ARTERY BYPASS GRAFT) BLOOD LOSS: UNKNOWN POSSIBLY DEVICE FAILURE/ PRE-EXISTING CONDITION/ PROCEDURE RELATED PATIENT OUTCOME: THE PATIENT'S CONDITION WAS NOT SERIOUS. THE PATIENT HAS RECOVERED. FOLLOW UP 1: THIS EVENT IS BEING SUBMITTED AS A FOLLOW UP #1 FOR MFG REPORT NUMBER 9612515-2024-00054 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).

  Patient problems: Seroma

  MAUDE report 19972593 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090987. 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