Phasix 1202530Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741095375), received between Apr 11, 2017 and Feb 14, 2026 — classified as 7 injuries, 1 malfunction.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2018¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SEPRAMESH IP MESH (DEVICE 1). PER OPERATIVE NOTES, ¿IN THE MIDLINE, THROUGH THE PRIOR INCISION, A HERNIA SAC FROM THE SURROUNDING TISSUES WERE EXCISED AND SEPRAMESH IP (DEVICE 1) WAS PLACED IN AN UNDERLAY FASHION AND SUTURED IN PLACE WITH SUTURES. THE WOUND WAS IRRIGATED AND FASCIA WAS CLOSED WITH SUTURES.¿ (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SEPRAMESH IP MESH (DEVICE 2). PER OPERATIVE NOTES, ¿JUST SUPERIOR TO THE PRIOR INCISION, A HERNIA WITH SAC WAS DISSECTED AWAY COMPLETELY ALL THE WAY DOWN TO LEVEL OF ANTERIOR FASCIA AND REMOVED. A PIECE OF SEPRAMESH IP (DEVICE 2) WAS PLACED OVER THE DEFECT AND SUTURED IN UNDERLAY FASHION CIRCUMFERENTIALLY.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT LAPAROSCOPIC CONVERTED INTO OPEN REPAIR WITH REMOVAL OF PRIOR MESHES (DEVICE 1 AND 2) AND IMPLANT OF PHASIX ST MESH (DEVICE 3). PER OPERATIVE NOTES, ¿THERE WAS INCARCERATED OMENTAL FAT WITH THE SMALL HERNIA

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24340582 ↗
• InjuryAug 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER MEDICAL AND PLAINTIFF PROFILE FORM: (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH PARASTOMAL HERNIA WITH OBSTRUCTION, INCISIONAL HERNIA WITH MULTIPLE FASCIAL DEFECTS WITH OBSTRUCTION, KNOWN HOSTILE ABDOMEN THEREBY UNDERWENT ROBOT ASSISTED REPAIR WITH THE IMPLANT OF VENTRALIGHT ST W/ ECHO 2 MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS DISSECTED. A VENTRALIGHT ST W/ ECHO 2 MESH (DEVICE #1) PLACED AND SECURE IT WITH SUTURE.¿ (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH PNEUMOPERITONEUM SECONDARY TO VERY SMALL ENTEROTOMY WITHOUT SIGNIFICANT INTRAPERITONEAL CONTAMINATION, ACUTE HYPOXEMIC CONTAMINATION, SEVER SEPSIS THEREBY UNDERWENT LAPAROSCOPIC REPAIR OF ENTEROTOMY, INTRAPERITONEAL DRAIN PLACEMENT. (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH INFECTED ABDOMINAL WALL MESH, INCISIONAL HERNIA, PARASTOMAL HERNIA, FISTULA, GRANULOMA, ADHESIONS THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALIGHT ST W/ ECHO 2 MESH (DEVICE #1) AND IMPLANT OF PHASIX ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED. INFECTED VENTRALIGHT ST W/ ECHO 2 MESH (DEVICE #1) WAS REMOVED. FISTULA, ADHESIONS WERE TAKEN DOWN. A PHASIX ST MESH (DEVICE #2) WAS PLACED AND SECURE IT WITH SUTURE.¿ (

  Patient problems: Adhesion(s); Hernia; Unspecified Infection

  MAUDE report 22737798 ↗
• InjuryJul 5, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY ATTORNEY: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH LARGE INCARCERATED VENTRAL HERNIAS AND UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO SEPRAMESH IP MESHES (DEVICE #1, DEVICE #2). PER OPERATIVE NOTES, " SEVERAL SMALL DEFECTS AND A LARGE DEFECT WAS ENCOUNTERED. A PIECE OF (SEPRAMESH ¿ DEVICE #2) MESH WAS SEWN TO ANOTHER PIECE OF (SEPRAMESH ¿ DEVICE #1) MESH USING SUTURES. THE MESH WAS TACKED USING MULTIPLE SPIRAL TACKS." (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INCISIONAL SITE WOUND DEHISCENCE. (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH LARGE VENTRAL HERNIA WITH CHRONIC ABDOMINAL WOUND AND UNDERWENT INCISION AND DEBRIDEMENT OF ABDOMINAL WALL WITH PLACEMENT OF VACUUM ASSISTED CLOSURE. PER OPERATIVE NOTE, ¿THERE WAS NO MESH EXPOSED¿. (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH ENTEROCUTANEOUS FISTULA WITH INFECTED ABDOMINAL WALL MESH AND UNDERWENT OPEN REPAIR FOR THE REMOVAL OF INFECTED MESH. PER OPERATIVE NOTES, "THE MESH WAS SEPARATED FROM THE UNDERLYING BOWEL, AND ENTEROCUTANEOUS FISTULA, WHICH WAS ADHERENT TO THE OVERLYING MESH, WHICH APPEARED TO HAVE ERODED INTO THE BOWEL. THE SPILLAGE OF BOWEL CONTENTS WERE CONTROLLED BY CLAMPS. THE MESH WAS SEPARATED AND

  Patient problems: Abscess; Drug Resistant Bacterial Infection; Pain; Seroma

  MAUDE report 17258823 ↗
• MalfunctionMay 31, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, UPON OPENING OF THE PHASIX ST MESH PACKAGE, A FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE POUCH. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER MESH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032870 ↗
• InjuryOct 12, 2022Incorrect, Inadequate or Imprecise Result or Readings; Biocompatibility; Incorrect, Inadequate or Imprecise Result or Readings; Biocompatibility

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH A VENTRALIGHT ST MESH IN 2018 AND DUE TO ¿SEVERE FIBROSIS OF THE ABDOMINAL MUSCLE¿ ¿CHRONIC ABDOMINAL PAIN¿ AND ¿INFLAMMATION¿ THE PATIENT UNDERWENT EXPLANT OF THE VENTRALIGHT ST MESH, ON (B)(6) 2020. DURING THIS PROCEDURE, THE PATIENT WAS IMPLANTED WITH A PHASIX ST MESH. IT WAS REPORTED THE PATIENT EXPERIENCED ¿SEVERE ABDOMINAL SWELLING, REDNESS, HEAT, AND PAIN¿ AND VISITED THE ER ON TWO OCCASIONS A MONTH AND HALF AFTER THE IMPLANT (PHASIX ST MESH) WAS PLACED. AS REPORTED THE PATIENT HAS UNDERGONE CT SCANS AND MIR. AS ALLEGED, PER RADIOLOGY REPORTS (NOT PROVIDED), ¿THE MESH HAS NOT DISSOLVED, THE SPECIALISTS ARE CITING MESH REJECTION.¿ REPORTEDLY, THE PATIENT IS UNDER ONGOING CARE WITH MULTIPLE SPECIALISTS/DOCTORS.

  Patient problems: Local Reaction; Pain; Swelling/ Edema

  MAUDE report 15587176 ↗
• InjurySep 1, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT AN OSTOMY REVERSAL ON (B)(6) 2020 WITH IMPLANT OF A PHASIX ST MESH IN AN IN UNDERLAY FASHION. AS REPORTED, PROCEDURE WAS CONSIDERED TO BE "CLEAN-CONTAMINATED" AND THERE WAS NO SIGNIFICANT AMOUNT OF SPILLAGE (BOWEL) DURING THE PROCEDURE. THE PATIENT WAS READMITTED WITH FLUID COLLECTION/ABSCESS ON (B)(6) 2020 WITH NO CLEAR SINUS TRACK AT THAT TIME AND WAS TREATED WITH MULTIPLE ROUNDS OF ANTIBIOTICS. AS REPORTED, THE PATIENT HAD IR (INTERVENTIONAL RADIOLOGY) DRAINS PLACED DURING (B)(6) 2021. IT WAS REPORTED THAT THERE WAS A SINUS TRACK TO THE BOWEL NOTED ON (B)(6) 2021, DURING AN IR (INTERVENTIONAL RADIOLOGY) DRAIN CHECK FOR THE DRAIN PLACED ON (B)(6) 2021.

  Patient problems: Abscess; Fistula; Unspecified Infection

  MAUDE report 12410559 ↗
• InjurySep 7, 2018Material Too Rigid or Stiff; Material Deformation; Material Too Rigid or Stiff; Material Deformation

  AS REPORTED ON (B)(6) 2018 A DAVOL PHASIX ST MESH WAS USED ON THE PATIENT AS A BRIDGE FOR OPEN ABDOMEN AFTER DIVERTED WITH ILEOSTOMY FOR ANASTOMOTIC LEAK AFTER A PERFORATED APPENDECTOMY WHO HAD SMALL BOWEL RESECTION AND ILEOCECOSTOMY. THE ABDOMEN WAS CLOSED WITH PHASIX ST MESH AS A BRIDGE, AND VAC WAS APPLIED. THE PLACEMENT OF THE PHASIX ST WAS INTENDED TO BE TEMPORARY AND WAS EXPLANTED LESS THAN 6 MONTHS LATER DURING THE REVERSE ILEOILEOSTOMY. AS REPORTED UPON EXPLANT THE MESH WAS NOTED TO HAVE HARDENED WITH TISSUE INGROWTH AND THERE WAS BOWEL STUCK TO IT. THE BOWEL WAS ABLE TO BE MOBILIZED SAFELY WITH NO BOWEL INJURY.

  Patient problems: Adhesion(s)

  MAUDE report 7854929 ↗
• InjuryApr 11, 2017No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED AND IS ASSOCIATED WITH THE (B)(6)CLINICAL STUDY - (B)(6): ON (B)(6) 2016 - THE PATIENT UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPIC PARASTOMAL HERNIA REPAIR USING A BARD PHASIX ST MESH AS PART OF THE ATLAS STUDY AND LEFT SIDED TRANSVERSUS ABDOMINUS PLANE BLOCK. OPERATIVE DETAIL NOTES THE PHASIX ST MESH TO HAVE MEASURED 12 X 10 INCHES AND WAS CUT DOWN TO 10 X 8 INCHES AND ORIENTED LONGITUDINALLY WITH A SLIT CUT ALONG THE MEDIAL ASPECT. DICTATION ALSO NOTES: "THE MESH WAS THEN PREPARED IN A C CONFIGURATION WITH A SLIT CUT ALONG THE MEDIAL ASPECT WITH THE ANTI-ADHESIVE BARRIER MADE TO FACE THE INTRA-ABDOMINAL CONTENTS." THE SIZE OF THE DEFECT MEASURED 6 CM IN LENGTH AND 6 CM IN WIDTH, TOTAL SIZE OF HERNIA 28.3. THE MESH WAS PLACED WITH AT LEAST 5 CM OVERLAP OF THE DEFECT. MESH WAS SECURED WITH A NON BARD/DAVOL DEVICE. THIS IS NOTED AS A FIRST TIME, PRIMARY INCISIONAL HERNIA. ON (B)(6) 2017 - THE PATIENT WAS DIAGNOSED WITH A RECURRENT PARASTOMAL HERNIA. ASSESSED TO BE MODERATE SEVERITY WITH INTERVENTION REQUIRED.

  Patient problems: Hernia

  MAUDE report 6481639 ↗