XENMATRIX 1153030Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741129032), received between Apr 17, 2018 and Apr 17, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WHO IS PART OF A CLINICAL STUDY HAS BEEN DIAGNOSED WITH A SEROMA. ON (B)(6) 2017 THE SUBJECT PATIENT UNDERWENT REPAIR OF A SUBXIPHOID, EPIGASTRIC HERNIA USING A XENMATRIX AB GRAFT. CONCOMITANT PROCEDURES WERE ALSO PERFORMED AT THIS TIME AND INCLUDED, REMOVAL OF DEEP FOREIGN BODIES, MUSCLE X2, AN ADJACENT TISSUE TRANSFER AND LYSIS OF ADHESIONS. THE HERNIA IS NOTED TO BE A PRIMARY VENTRAL HERNIA AND ASSESSED TO BE A CLASS 1 (CLEAN) WOUND SITE PRE OPERATIVELY. THE CASE WAS PERFORMED IN RETRO RECTUS FASHION WITH COMPONENT SEPARATION TECHNIQUE (POSTERIOR). A TAR (TRANSVERSUS ABDOMINIS MUSCLE RELEASE) TECHNIQUE WAS UTILIZED. XENMATRIX AB GRAFT WAS PLACED WITH A 5CM GRAFT OVERLAP AROUND THE HERNIA DEFECT. LONG-TERM ABSORBABLE MONOFILAMENT SUTURE WAS USED FOR PERIMETER FIXATION OF THE GRAFT. THE MIDLINE FASCIA WAS COMPLETELY CLOSED. THE SKIN WAS NOT FULLY CLOSED AND A VACUUM ASSISTED CLOSURE WAS PERFORMED. DRAINS WERE INSERTED IN THE RIGHT UPPER QUADRANT, LEFT UPPER QUADRANT AND IN THE SUBCUTANEOUS SPACE. THE DRAINS AND VACUUM WERE REMOVED ON (B)(6) 2017 AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2017 THE PATIENT WAS DIAGNOSED WITH A SEROMA.

  Patient problems: Seroma

  MAUDE report 7437250 ↗