Gelsoft™ Cardiovascular Patch 960701Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05037881010656), received between Nov 25, 2021 and Nov 20, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K200955, K963611); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025Obstruction of Flow; Obstruction of Flow

  CLINICAL TRIAL (B)(4), POST-OPERATIVELY ON (B)(6) 25 THE PATIENT PRESENTED WITH THE SERIOUS ADVERSE EVENT OF OCCLUSION IN FEMORAL ARTERY. THE PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2025 FOR EMBOLECTOMY OF THE LEFT LEG WITH PATCH ANGIOPLASTY OF THE COMMON FEMORAL ARTERY AND STENTING OF THE COMMON ILIAC ARTERY. DURING THE PATCH ANGIOPLASTY, THE GELSOFT PATCH WAS CUT AND THE NEW BOVINE PATCH WAS SEWN NEXT TO (SUTURED TO) THE EXISTING GELSOFT PATCH. THERE WAS A POSTOPERATIVE BLEEDING THAT REQUIRED REVISION WITH HAEMOSTASIS AND IMAGING SHOWED DIFFUSE OOZING WITHOUT ANY MAJOR BLEEDING. THE PATIENT WAS DISCHARGED ON POST-OPERATIVELY ON (B)(6) 2025 AND THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE. THE INVESTIGATOR CONSIDERED THE EVENT TO BE POSSIBLY RELATED TO THE DEVICE AND RELATED TO THE PRE-EXISTING CONDITION. THE PATIENT REMAINS IN THE STUDY AND WILL CONTINUE TO BE FOLLOWED UP. THE SITE CONFIRMED THAT THE REINTERVENTION WAS NOT REQUIRED AS A RESULT OF ANY DEVICE DEFICIENCY. THIS REPORT IS BEING SUBMITTED AS FINAL FOR MANUFACTURING REPORT NUMBER 9612515-2025-00095 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0349.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23602290 ↗
• MalfunctionDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS REPORTED VIA THE PANTHER STUDY. REPORTED WOUND COMPLICATIONS FOLLOWING IMPLANTATION OF A CARDIOVASCULAR PATCH IN THE FEMORAL AREA. THE SITE REPORTED POSSIBLE INFECTION DESPITE NEGATIVE TEST RESULTS BY THE SITES LAB TESTING.

  Patient problems: Local Reaction

  MAUDE report 13007987 ↗
• MalfunctionNov 25, 2021Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem

  EVENT WAS REPORTED FROM PANTHER STUDY AS BLEEDING / BLOOD LOSS - BLEEDING IN THE RECOVERY WARD - COMPRESSION WAS APPLIED AND NO LMWH (LOW MOLECULAR WEIGHT HEPARIN) ADMINISTERED POST OPERATIVELY ON DAY 1. THE SITE ALSO INDICATED THAT THERE WAS SOME MILD PATCH LEAKAGE, AT THE ANASTOMOTIC SITE WHICH THEY MANAGED WITH PROTAMIN ADMINISTRATION AND MANUAL COMPRESSION. IT WAS ALSO INDICATED THAT THERE WAS SOME SUTURE HOLE BLEEDING - PATIENT UNDER DUAL ANTIPLATELET AND AFTER ENDARTERECTOMY GROIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12874576 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200955, K963611. One submission often covers many models, so check the product and lot details in each record.

• Z-2543-2021 · Jul 8, 2021 · Terminated
  The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t