Phasix 1192040Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741107634), received between Apr 26, 2021 and Apr 10, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2026Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL (B)(6): THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 AND UNDERWENT AN OPEN PRIMARY LAPAROTOMY, COLECTOMY, EXPLORATORY LAPAROTOMY AND SMALL BOWEL RESECTION DURING WHICH A PHASIX FLAT MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MONOFILAMENT SUTURES WITH 2-0 PDS. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH (39 CM LENGTH AND 6 CM WIDTH). THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ETHICON SLOW ABSORBING MONOFILAMENT WITH RUNNING STITCHES APPROXIMATELY 1 CM FAR APART AND 30 CM IN LENGTH. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2026. ON (B)(6) 2026, THE SUBJECT PATIENT DEVELOPED A SMALL SEROMA ON INCISION SITE, NO TREATMENT OR TEST DONE. THE SEROMA WAS RESOLVED ON (B)(6) 2026. THE REPORTED ADVERSE EVENT (SEROMA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLE RELATED TO THE STUDY DEVICE AND A PROBABLE RELATIONSHIP TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY AND RECOVERED AND RESOLVED; THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

  Patient problems: Seroma

  MAUDE report 24839738 ↗
• InjuryFeb 18, 2026Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT UNDERWENT AN OPEN EXPLORATORY PRIMARY LAPAROTOMY WITH CONCOMITANT PROCEDURES HYSTERECTOMY, OOPHORECTOMY, LEFT SALPINGECTOMY AND RIGHT SALPINGO-OOPHORECTOMY ON (B)(6) 2023, DURING WHICH A BARD/DAVOL PHASIX MESH WAS TRIMMED, PLACED IN ONLAY FASHION AND SECURED IN PLACE. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH SLOW ABSORBING MONOFILAMENT 1 PDS SUTURES. A 3CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. SKIN CLOSURE WAS ACHIEVED BY RUNNING STITCH WITH LONG TERM ABSORBABLE SUTURES. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2023. ON (B)(6) 2023, THE SUBJECT PATIENT WAS DIAGNOSED WITH SUPERFICIAL SURGICAL SITE INFECTION AND REQUIRED MEDICATION. (NOTE THE SSI RESOLVED ON 01-FEB-2024 AND WAS REPORTED TO THE FDA REFERENCE (B)(4). ON (B)(6) 2025, THE SUBJECT PATIENT WAS DIAGNOSED WITH A HERNIA OCCURRENCE THROUGH CT SCAN. AS REPORTED, THE ADVERSE EVENT (HERNIA) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE WITH A CAUSAL RELATIONSHIP TO THE PROCEDURE AND NOT RECOVERED/ NOT RESOLVED. THE SEVERITY HAS BEEN ASSESSED AS MILD. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVER

  Patient problems: Hernia

  MAUDE report 24376757 ↗
• InjuryJul 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL DVL-HE-018: THE SUBJECT PATIENT UNDERWENT LAPAROSCOPIC PRIMARY COLECTOMY AND EXPLORATORY LAPAROTOMY ON (B)(6) 2025 DURING WHICH A PHASIX MESH WAS TRIMMED, PLACED IN AN ONLAY FASHION AND SECURED USING ABSORBABLE MULTIFILAMENT SUTURES. A 3 CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2025. ON (B)(6) 2025, PATIENT WITH BULGE IDENTIFIED AT POST-OP VISIT WITH NP. SEROMA WAS DIAGNOSED VIA CT SCAN. THE REPORTED ADVERSE EVENT (SEROMA) HAS BEEN ASSESSED PER CLINICIANS AS CAUSALLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, AND IT HAS RECOVERED/RESOLVED ON (B)(6) 2025. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF UADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

  Patient problems: Seroma

  MAUDE report 22393653 ↗
• InjuryFeb 22, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL (B)(4) : ON (B)(6) 2024, THE SUBJECT PATIENT UNDERWENT AN OPEN EXPLORATORY PRIMARY LAPAROTOMY WITH CONCOMITANT PROCEDURE LYSIS OF ADHESIONS WITH THE IMPLANT OF A PHASIX MESH. THE MESH WAS TRIMMED, PLACED IN ONLAY FASHION, AND FIXATED BY MECHANICAL FIXATION WITH 15 FIXATION POINTS. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH SLOW ABSORBING MONOFILAMENT 0 PDS SUTURES. A 3CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. SKIN CLOSURE WAS ACHIEVED BY STAPLES. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT VISITED THE HOSPITAL AND WAS DIAGNOSED WITH SURGICAL SITE INFECTION THROUGH CLINICAL ASSESSMENT. AS REPORTED, THE MANUAL OPENING OF WOUND WAS PERFORMED AT BEDSIDE. THE FLUID WAS EXTRACTED, AND THE DRAINAGE CULTURES WERE COLLECTED. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS/ANTIMICROBIALS INTRAVENOUSLY. PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024. THE REPORTED ADVERSE EVENT (SURGICAL SITE INFECTION) HAS BEEN ASSESSED PER CLINICIAN AS DEFINITELY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THE AE HAS BEEN ASSESSED AS MODERATE IN SEVERITY. THE REPORTED AE DOES MEET THE DEFINIT

  Patient problems: Unspecified Infection

  MAUDE report 18757206 ↗
• InjuryJan 31, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER THE CLINICAL TRIAL (B)(6): THE SUBJECT PATIENT UNDERWENT AN OPEN EXPLORATORY PRIMARY LAPAROTOMY WITH CONCOMITANT PROCEDURES HYSTERECTOMY, OOPHORECTOMY, LEFT SALPINGECTOMY AND RIGHT SALPINGO-OOPHORECTOMY ON (B)(6) 2023, DURING WHICH A BARD/DAVOL PHASIX MESH WAS TRIMMED, PLACED IN ONLAY FASHION AND SECURED IN PLACE. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH SLOW ABSORBING MONOFILAMENT 1 PDS SUTURES. A 3CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. SKIN CLOSURE WAS ACHIEVED BY RUNNING STITCH WITH LONG TERM ABSORBABLE SUTURES. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2023. ON (B)(6) 2023, THE SUBJECT PATIENT WAS DIAGNOSED WITH SUPERFICIAL SURGICAL SITE INFECTION AND REQUIRED MEDICATION. THE REPORTED ADVERSE EVENT (SURGICAL SITE INFECTION) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE, DEFINITELY RELATED TO THE PROCEDURE AND RECOVERING/RESOLVING. THE AE HAS BEEN ASSESSED AS MILD IN SEVERITY. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND UADE (UNANTICIPATED ADVERSE DEVICE EVENT). ADDENDUM PER ADDITIONAL INFORMATION RECEIVED: THE SUBJECT PATIENT WAS DIAGNOSED WITH SUPERFICIAL SURGICAL SITE

  Patient problems: Unspecified Infection

  MAUDE report 18612599 ↗
• InjuryJun 7, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER THE CLINICAL TRIAL (B)(4): ON (B)(6) 2023, THE SUBJECT PATIENT UNDERWENT AN OPEN EXPLORATORY RELAPAROTOMY-COLOSTOMY REVERSAL PROCEDURE DURING WHICH A PHASIX MESH WAS TRIMMED AND IMPLANTED IN ONLAY FASHION USING ABSORBABLE MONOFILAMENT 2-0 PDS SUTURES. A 3CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT WAS DIAGNOSED WITH SURGICAL SITE INFECTION WHICH REQUIRED HOSPITALIZATION. THIS ADVERSE EVENT HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE ADVERSE EVENT HAS BEEN ASSESSED AS RECOVERING/RESOLVING, MODERATE IN SEVERITY AND A SAE (SERIOUS ADVERSE EVENT) BUT DOES NOT MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).

  Patient problems: Unspecified Infection

  MAUDE report 17078415 ↗
• InjuryJan 19, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER PREVENT CLINICAL TRIAL DVL-HE-018: ON (B)(6) 2022, THE SUBJECT PATIENT UNDERWENT PRIMARY LAPAROTOMY-OPEN AORTOILIAC BYPASS DURING WHICH A PHASIX MESH WAS TRIMMED AND SECURED IN PLACE WITH 2-0 PDS SUTURES. PROPHYLACTIC ANTIBIOTIC CEFAZOLIN WAS USED PERIOPERATIVELY. ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH SEROMA AND WAS ADMITTED ON THE SAME DAY. IT WAS REPORTED THAT THE PATIENT REQUIRED IR PLACED DRAIN. FLUID CULTURES OF SEROMA WERE NEGATIVE. DURING THIS STAY THE PATIENT WAS DIAGNOSED WITH WOUND DEHISCENCE. THE ADVERSE EVENT OF SEROMA WAS ASSESSED PER CLINICIAN AS MODERATE SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE, AND DEFINITELY RELATED TO THE PROCEDURE AND RECOVERING/RESOLVING. THE WOUND DEHISCENCE WAS ASSESSED PER CLINICIAN AS MODERATE SEVERITY MODERATE SEVERITY AND NOT RECOVERED/NOT RESOLVED. THE ADVERSE EVENT HAS BEEN ASSESSED AS A SERIOUS ADVERSE EVENT (SAE) AND THE EVENT DOES NOT MEET THE DEFINITION OF AN UNANTICIPATED ADVERSE DEVICE EFFECT (UADE). ADDENDUM PER ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2023, THE PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS AND WAS ADMITTED ON THE SAME DAY. THE ABSCESS CULTURE TESTED POSITIVE FOR A DRUG RESISTA

  Patient problems: Abscess; Drug Resistant Bacterial Infection; Seroma; Wound Dehiscence

  MAUDE report 16210134 ↗
• MalfunctionApr 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER PREVENT CLINICAL TRIAL (B)(4): ON (B)(6) 2021, THE PATIENT UNDERWENT AN OPEN HEPATICOJEJUNOSTOMY AND CHOLECYSTECTOMY PROCEDURE AND A BARD/DAVOL PHASIX MESH WAS TRIMMED AND PLACED IN ONLAY FASHION WITH 3 CM OVERLAP IN ALL DIRECTIONS. THE MESH WAS SUTURED IN PLACE WITH NON-BARD/DAVOL ABSORBABLE MULTIFILAMENT SUTURES. AS REPORTED, THE PATIENT WAS DIAGNOSED WITH DIASTASIS RECTION (B)(6) 2021. THE AE IS REPORTED TO HAVE NOT RESOLVED, AND NO TREATMENT HAS BEEN PROVIDED. THE ADVERSE EVENT HAS BEEN ASSESSED AS MILD SEVERITY AND AS NOT A SERIOUS ADVERSE EVENT (SAE) OR AN UNANTICIPATED ADVERSE DEVICE EFFECT, (UADE) BY THE STUDY GROUP. THE ADVERSE EVENT HAS BEEN ASSESSED PER STUDY CLINICIAN AS NOT RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE INDEX PROCEDURE. THE ADVERSE EVENT HAS BEEN ASSESSED PER CEC CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 14140676 ↗
• InjuryAug 4, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED SEROMA POST-IMPLANT OF PHASIX MESH. (B)(6) 2021 - THE PATIENT UNDERWENT AN OPEN HEPATICOJEJUNOSTOMY. A BARD/DAVOL PHASIX MESH 20X40CM, WAS TRIMMED AND PLACED IN ONLAY FASHION. THE MESH WAS TRIMMED AND 3CM OVERLAP WAS ACHIEVED IN ALL DIRECTIONS. THE PHASIX MESH WAS SECURED IN PLACE WITH SUTURE FIXATION ONLY AND THE MIDLINE FASCIA WAS CLOSED BY RUNNING STITCH USING NON BARD/DAVOL 2-0 PDS SUTURE. THE SKIN WAS FULLY CLOSED WITH SUTURE AND SURGICAL GLUE. A DRAIN WAS PLACED DURING THE INDEX PROCEDURE, INTRAPERITONEALLY IN THE RIGHT UPPER QUADRANT OF THE ABDOMEN. (B)(6) 2021 - THE DRAIN WAS REMOVED. (B)(6) 2021 - THE SUBJECT PATIENT WAS DIAGNOSED WITH A SEROMA. (B)(6) 2021 - THE AE HAS RESOLVED AND THE SUBJECT PATIENT HAS RECOVERED. THE ADVERSE EVENT HAS BEEN ASSESSED PER CLINICIAN AS DEFINITELY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE INDEX PROCEDURE. NO ADDITIONAL SURGICAL INTERVENTION HAS BEEN PROVIDED AT THIS TIME. THE ADVERSE EVENT HAS BEEN ASSESSED AS MILD SEVERITY AND NOT A SERIOUS ADVERSE EVENT (SAE) OR A (UNANTICIPATED ADVERSE DEVICE EFFECT (UADE).

  Patient problems: Seroma

  MAUDE report 12273469 ↗
• InjuryApr 26, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED SEROMA AND SMALL SKIN DEHISCENCE POST-IMPLANT OF PHASIX MESH. (B)(6) 2021 - THE SUBJECT PATIENT UNDERWENT AN OPEN EXPLORATORY LAPAROTOMY WITH A BOWEL RESECTION, LYSIS OF ADHESIONS AND OSTOMY REVISION. A BARD/DAVOL PHASIX MESH WAS TRIMMED AND PLACED IN ONLAY FASHION. MECHANICAL FIXATION (NON-BARD/DAVOL) WAS USED TO SECURE THE MESH. THE MESH WAS TRIMMED AND ADEQUATE OVERLAP OF THE DEFECT WAS ACHIEVED. FASCIAL CLOSURE WAS ACHIEVED WITH NON-BARD/DAVOL SUTURE, IN A RUNNING STITCH TECHNIQUE. IT WAS REPORTED THAT PROPHYLACTIC ANTIBIOTIC (CEFOTETAN) WAS ADMINISTERED TO THE PATIENT PERI-OPERATIVELY. (B)(6) 2021 - THE PATIENT WAS DISCHARGED HOME. (B)(6) 2021 - THE SUBJECT PATIENT WAS DIAGNOSED WITH AN APPROXIMATELY 2CM SEROMA CAUSING SMALL SKIN DEHISCENCE. AS REPORTED, THE PATIENT HAS BEEN INSTRUCTED TO RETURN TO CLINIC IN 2 WEEKS AND TO PACK THE WOUND TWICE A DAY WITH DRY GAUZE, AND SWITCH TO SALINE GAUZE ONCE DRAINAGE DECREASES. THE PATIENT HAD ALSO BEEN INSTRUCTED TO SWITCH TO AQUACEL ROPE IN A WEEK. NO ADDITIONAL SURGICAL INTERVENTION HAS BEEN PROVIDED AT THIS TIME. AS REPORTED, THE REPORTED ADVERSE EVENT

  Patient problems: Seroma; Wound Dehiscence

  MAUDE report 11725455 ↗