Phasix 1220011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741163173), received between Mar 23, 2020 and Jul 15, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY REPAIR OF HARTMANN'S REVERSAL PROCEDURE FOR 4 X 2CM SIZED HERNIA DEFECT, IN WHICH PHASIX ST W/ OPEN POSITIONING SYSTEM WAS USED TO REINFORCE THE STOMA SITE, NEAR AN ANASTOMOTIC LEAK ON (B)(6) 2019. THE MESH WAS PRE-HYDRATED WITH SALINE SOLUTION FOR 3 SECONDS AND IMPLANTED INTRA-ABDOMINALLY WITH THE BARRIER FACING DOWNWARD. THE MESH WAS FIXATED CIRCUMFERENTIALLY WITH A NON-BARD/DAVOL FIXATION DEVICE PLACED APPROXIMATELY 1-2CM APART AND SECURED WITH SUTURES. THE HERNIA DEFECT WAS CLOSED PRIMARILY AND THE MESH OVERLAP WAS 3.5CM. FOLLOWING FIXATION, THE POSITIONING SYSTEM WAS REMOVED AND THE FASCIA WAS CLOSED OVER THE MESH. POST-IMPLANT, THE PATIENT DEVELOPED ABDOMINAL PAIN, THE SURGEON ORIGINALLY BELIEVED IT WAS PAIN FROM AN INCISIONAL HERNIA AND BROUGHT THE PATIENT BACK FOR HERNIA REPAIR ON (B)(6) 2020. INTRAOPERATIVELY, THE SURGEON DISCOVERED AN UNDIAGNOSED BOWEL OBSTRUCTION AT THE SITE OF DENSE ADHESIONS/INGROWTH OF THE BOWEL TO THE PHASIX ST OPEN MESH; THE MESH WAS STILL MOSTLY INTACT. A BOWEL RESECTION WAS PERFORMED AND THE REMOVED PORTION HAD A HARDENED FEEL, THAT THE SURGEON FOUND VERY ABNORMAL, AND PIECES OF MESH WERE STILL

  Patient problems: Abdominal Pain; Adhesion(s); Obstruction/Occlusion

  MAUDE report 10279812 ↗
• InjuryMar 23, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT WAS IMPLANTED INTRA-ABDOMINALLY WITH A BARD PHASIX ST MESH (OPS) DURING AN OPEN UMBILICAL HERNIA REPAIR PROCEDURE. AS REPORTED THE MESH WAS NOT HYDRATED PRIOR TO IMPLANT. THE SEPRA (ST) BARRIER WAS PROPERLY ORIENTED TOWARD THE BOWEL WITH THE MESH SIDE TOWARD THE ABDOMINAL WALL. ON (B)(6) 2020 DUE TO AN OBSTRUCTION THE PATIENT WAS BOUGHT BACK TO THE OR AND UNDERWENT EXPLANT OF THE MESH. DENSE ADHESIONS TO THE MESH WERE REPORTED. THE DOCTOR NOTED THAT IN A PHOTO TAKEN OF THE BOWEL YOU CAN "CLEARLY SEE WHERE THE DISTENDED BOWEL AND DILATED BOWEL ARE THAT CAUSED THE OBSTRUCTION AND IN THE CENTER YOU CAN SEE THE LEFT BEHIND SEPRAFILM FROM THE MESH."

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 9864835 ↗