Phasix 1190100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741077661), received between Feb 3, 2021 and Nov 12, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE 1). PER OP NOTES, ¿LAPAROSCOPIC APPENDECTOMY WAS DONE. AN UMBILICAL HERNIA WAS NOTED ALONG WITH ANOTHER SMALL HERNIA WERE COALESCED INTO ONE DEFECT. A VENTRALEX ST MESH (DEVICE 1) WAS PLACED INTO ABDOMEN AND SUTURED.¿ ON (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA; SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX MESH (DEVICE 2). PER OP NOTES, ¿THE ABDOMINAL HERNIA WAS NOTED. ADHESIONS WERE TAKEN DOWN. A PHASIX MESH (DEVICE 2) WAS PLACED OVER THE DEFECT USING SUTURES.¿ (NOTE: THERE IS NO MENTION/VISUALIZATION OF DEVICE 1 IN THIS PROCEDURE.) ON (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH REDUCIBLE RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1, 2) AND IMPLANT OF VENTRALEX ST MESH (DEVICE 3). PER OP NOTES, ¿THE FASCIAL DEFECT WAS IDENTIFIED. THE ADHESIONS WERE TAKEN DOWN. THE PREVIOUS MESH (DEVICE 1 AND 2) WAS REMOVED. A VENTRALEX ST MESH (DEVICE 3) WAS PLACED INTO THE ABDOMINAL CAVITY AND SECURED USING SUTURES.¿

  Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion

  MAUDE report 23531412 ↗
• InjuryJul 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #1). PER OPERATIVE NOTES, "MODERATE SIZE RECURRENT INCARCERATED INCISIONAL HERNIA WAS NOTED AND OPENED, INCARCERATED OMENTUM IN THE SAC WAS TEASED. A VENTRIO ST MESH (DEVICE #1) WAS PLACED AND SUTURED." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF MASS AND IMPLANT OF PHASIX MESH (DEVICE #2). PER OPERATIVE NOTES, "A HERNIA SAC WAS IDENTIFIED AT THE SUPERIOR ASPECT OF THE OLD INCISION WITH INCARCERATED OMENTUM. THE SAC WAS OPENED AND FREED. DENSE ADHERENCE TO THE UNDERLYING ABDOMINAL SURFACE WAS NOTED. A PHASIX MESH (DEVICE #2) WAS PLACED AND SUTURED." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST (DEVICE #3) AND PHASIX MESH (DEVICE #4). PER OPERATIVE NOTES, "A LARGE HERNIA SAC EXTENDED FROM THE SUPERIOR ASPECT OF PREVIOUS REPAIR WAS NOTED AND REMOVED. THE INFERIOR PORTION OF WOUND HAD PREVIOUS MESH (DEVICE #1) WHICH WAS LEFT IN P

  Patient problems: Hernia

  MAUDE report 22394793 ↗
• InjuryFeb 3, 2021Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PHASIX ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE PHASIX. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 11271550 ↗