Phasix 1200011Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741095283), received between Feb 27, 2018 and Mar 4, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PHASIX ST MESH (DEVICE 1). PER OP NOTES, ¿A MIDLINE INCISION WAS MADE AROUND THE UMBILICUS AND THE OLD RECURRENT INCISIONAL HERNIA SCAR. THE HERNIA SAC WAS IDENTIFIED AND EXCISED. THE OLD SYNTHETIC MESH WAS EXCISED. A PHASIX ST MESH (DEVICE 1) WAS PLACED INTO THE PERITONEAL CAVITY AND SECURED WITH SUTURES.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXCISION OF PHASIX ST MESH (DEVICE 1) AND IMPLANT OF VENTRIO ST MESH (DEVICE 2). PER OP NOTES, ¿AN ELLIPTICAL INCISION WAS MADE AROUND THE OLD INCISION SCAR. THE HERNIA SAC WAS IDENTIFIED WITH SOME SEROUS FLUID. IT WAS SUCTIONED FREE FROM THE WOUND AND DISSECTED THE CAPSULE OFF THE UNDERLYING SCAR TISSUE. A SLIGHT BULGE IN THE SCAR FROM THE ABSORBED HERNIA PATCH AND SOME RESIDUAL PATCH WAS NOTED WHICH WAS EXCISED. A VENTRIO ST MESH (DEVICE 2) WAS PLACED IN THE PERITONEUM AND TACKED TO THE FASCIA WITH ABSORBABLE TACKERS AND SECURED WITH SUTURES.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA

  Patient problems: Hernia; Scar Tissue; Seroma

  MAUDE report 24504576 ↗
• InjuryFeb 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL AND INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OP NOTES, "PREVIOUS SYNTHETIC MESH WAS EXCISED. A MEDIUM COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED BENEATH THE FASCIA AND PERITONEUM INTO THE ABDOMEN USING SUTURES." (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT REPAIR. PER OP NOTES, "THE PREVIOUS COMPOSIX KUGEL MESH WAS ATTACHED TO THE ABDOMINAL WALL." (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RIGHT ABDOMINAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 2). PER OP NOTES, "A BARD FLAT MESH (DEVICE 2) WAS SECURED UNDERLYING THE FASCIA." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE 1 AND 2) AND IMPLANT OF PHASIX ST (DEVICE 3), SMALL BOWEL RESECTION, LYSIS OF ADHESIONS. PER OP NOTES, "PATIENT HAS A BOWEL OBSTRUCTION, ADHESIONS WERE TAKEN DOWN. LOOP OF SMALL BOWEL THAT WAS ADHERENT TO AN OLD MESH THAT WAS CURLED ON ITSELF AND TOOK DOWN THE SMALL BOWEL OFF THE MESH. THE MESH (DEVICE 1 AND 2) WERE

  Patient problems: Abscess

  MAUDE report 24378476 ↗
• MalfunctionNov 25, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED ON (B)(6) 2025 DURING TWO SEPARATE CASES FOR HIATAL HERNIA REPAIR THE USER FACILITY REPORTS THAT THE FOIL POUCHES ONCE OPENED HAD PIN HOLES ALONG WITH DEEP SCRATCHES AND ARE CONCERNED THEY HAVE BEEN COMPROMISED. BREACH OF STERILITY. THEY ALLEGED THEY CAN SEE LIGHT THROUGH THE POUCH WHEN USING A FLASHLIGHT DURING INSPECTION. THE FACILITY PERFORMED AN INVENTORY INSPECTION OPENING MULTIPLE PRODUCTS (PHASIX ST, VENTRALIGHT ST, PHASIX OPS, PHASIX ECHO) WITH THE SAME CONDITION OF DAMAGE. THE TWO CASES WERE COMPLETED USING ANOTHER DEVICE THAT DID NOT EXHIBIT THE SAME ISSUE. THIS RESULTED IN AN INCONSEQUENTIAL DELAY. THERE WAS NO PATIENT HARM AS A RESULT OF THE PROBLEM EXPERIENCED. THIS MDR REPRESENTS THE 1 PHASIX ST MESH FROM LOT NUMBER HUJU1382 OPENED AT THE USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644941 ↗
• InjurySep 10, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, ¿TWO HERNIA SAC WERE IDENTIFIED AND EXCISED. A LARGE HERNIA WAS REPAIRED USING VENTRALEX MESH (DEVICE 1) AND SUTURED. ANOTHER DEFECT WAS REPAIRED USING SUTURES.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INFECTED MESH AND NON-HEALING WOUND THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXCISION OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, ¿SMALL AMOUNT OF PUS WAS OBTAINED. TISSUE AND PORTIONS OF INFECTED OLD MESH (DEVICE 1) WERE EXCISED. THE INFECTED TISSUES WERE DEBRIDED. THE REMAINING OLD MESH EDGES WERE SUTURED.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH COMPLICATED WOUND, INFECTED MESH AND RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALEX MESH (DEVICE 1) AND IMPLANT OF PHASIX ST (DEVICE 2). PER OP NOTES, ¿THE INFECTED MESH, ABDOMINAL WALL AND FASCIA WERE NOTED. INTRA-ABDOMINAL ADHESIONS WERE LYSED. THE NECROTIC FASCIA WAS EXCISED. THE SURROUNDING INFECTED TISSUES AND OLD MESH (DEVICE 1) WITH PUS WERE EXCISED ENTIRELY. THE HERNIA DEFECT WAS IDENTIFIED AND REPAIRED WITH PHASIX ST

  Patient problems: Impaired Healing; Necrosis; Unspecified Infection

  MAUDE report 23013759 ↗
• InjuryFeb 18, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND DISSECTED. A COMPOSIX OVAL MESH (DEVICE #1) WAS THEN PLACED INTO THE ABDOMINAL CAVITY AND SECURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH LARGE INCISIONAL HERNIA WITH CONTAMINATED MESH AND ADHESIONS THEREBY UNDERWENT REPAIR WITH IMPLANT OF PHASIX ST MESH (DEVICE #2) AND REMOVAL OF MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE MESH (DEVICE #1) AND IDENTIFIED AND DISSECTED FROM SURROUNDING AREA WHICH REVEALED ADHESIONS. A PHASIX ST MESH (DEVICE #2) WAS PLACED INTRAABDOMINALLY AND SUTURED.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT LARGE INCISIONAL ABDOMINAL WALL HERNIA AND ADHESIONS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE #3) AND COMPOSIX L/P MESH (DEVICE #4) AND LYSIS OF ADHESIONS. PER OPERATIVE NOTES, ¿THE PREVIOUSLY PLACED ONLAY PATCH (DEVICE #2) WAS NOTED TO BE INTACT AND THERE WERE ADHESIONS TO THE ANTERIOR ABDOMINAL CAVITY. A COMPOSIX MESHES (DEVICE #3 & #4) WAS PLACED IN THE AREA OF ABDOMINAL CAVITY AND SECU

  Patient problems: Abscess; Adhesion(s); Bacterial Infection; Hernia; Scar Tissue

  MAUDE report 21400726 ↗
• MalfunctionApr 1, 2020Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT ROBOTIC ASSISTED REPAIR OF AN ABDOMINAL HERNIA AND WAS IMPLANTED WITH A BARD PHASIX ST MESH. IT WAS LATER IDENTIFIED THAT THE LABELED EXPIRATION DATE FOR THE IMPLANTED MESH WAS 02/28/2020. AS REPORTED, THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913902 ↗
• InjuryOct 11, 2019Material Protrusion/Extrusion; Patient Device Interaction Problem; Material Protrusion/Extrusion; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO DAVOL: ON (B)(6) 2019 THE PATIENT, WHO HAS A COMPLEX SURGICAL HISTORY WHICH INCLUDES A COLON RESECTION AND COLOSTOMY, UNDERWENT REVERSAL OF THE COLOSTOMY. AT THIS TIME THE SURGEON PLACED A PHASIX ST MESH TO AID IN CLOSURE OF THE ABDOMEN. AS REPORTED, THE PATIENTS SURGICAL WOUND HAS NOT FULLY HEALED SINCE THE PROCEDURE AND THE PATIENT CONTINUES TO HAVE DRESSING CHANGES AND TREATMENT PROVIDED BY THE WOUND CLINIC. ALSO REPORTED, THE SURGEON HAS ADVISED THE PATIENT THAT SHE IS NOT A CANDIDATE TO UNDERGO ADDITIONAL SURGICAL INTERVENTION TO REMOVE THE MESH AS THE SURGEON STATED "THERE IS NOTHING LEFT TO WORK WITH." AS REPORTED, THE PATIENT HAS HAD MULTIPLE ABDOMINAL SURGERIES AND AS STATED, SHE "DIED ON THE TABLE" DURING ONE OF HER PREVIOUS PROCEDURES. AS REPORTED, THERE ARE PIECES OF THE MESH PROTRUDING FROM THE OPEN AREA OF THE WOUND.

  Patient problems: Impaired Healing

  MAUDE report 9179615 ↗
• InjuryOct 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT PARTICIPATING IN A PHASIX ST CLINICAL STUDY (B)(6) EXPERIENCED A HERNIA RECURRENCE. ON (B)(6) 2017 - THE PATIENT UNDERWENT ROBOTIC ASSISTED UMBILICAL HERNIA REPAIR AND WAS IMPLANTED WITH A BARD PHASIX ST MESH. POSTOPERATIVELY THE PATIENT DEVELOPED A SEROMA, WHICH RESOLVED WITHOUT INTERVENTION. ON (B)(6) 2018 - THE PATIENT WAS DIAGNOSED WITH A HERNIA RECURRENCE. THE RECURRENCE WAS ASSESSED BY THE CLINICIAN AS MILD IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE PROCEDURE. AT THIS TIME, NO INTERVENTION IS REQUIRED.

  Patient problems: Hernia; Seroma

  MAUDE report 7999637 ↗
• InjuryFeb 27, 2018Hole In Material; Insufficient Device Problem Information; Hole In Material; Insufficient Device Problem Information

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A RECURRENCE OF THE HERNIA 18 MONTHS POST IMPLANT. ON (B)(6) 2016 - THE PATIENT UNDERWENT LAPAROSCOPIC IMPLANT OF THE PHASIX ST MESH TO REPAIR AN UMBILICAL HERNIA. THE MESH WAS FIXATED WITH SUTURE AS WELL AS OPTIFIX FASTENERS. THE HERNIA DEFECT MEASURED 2.5CM IN LENGTH AND 2CMIN WIDTH. AS REPORTED THE PHASIX ST MESH WAS POSITIONED SO THAT ITS EDGES EXTENDED BEYOND THE MARGINS OF THE DEFECT BY AT LEAST 5CM. ON (B)(6) 2018 - 18 MONTH FOLLOW UP VISIT. THE PATIENT WAS DIAGNOSED WITH A HERNIA RECURRENCE. THE PATIENT WAS ALSO NOTED TO HAVE GAINED 25 LBS SINCE THE INDEX PROCEDURE. THE PATIENT IS NOT REPORTING ANY PAIN. ALSO AN AREA A DIASTASIS HAS BEEN IDENTIFIED UPON PHYSICAL EXAM IN THE AREA OF THE REPAIR, WHICH WAS ASSESSED AS NOT BEING RELATED TO THE STUDY DEVICE. THE HERNIA RECURRENCE HAS BEEN ASSESSED AS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE PATIENT HAS NOT RECEIVED TREATMENT AND IS NOT SCHEDULED FOR A REOPERATION AT THIS TIME.

  Patient problems: Hernia; Weight Changes

  MAUDE report 7299096 ↗