Phasix 1190820Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741107566), received between Apr 14, 2022 and Jan 9, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT UNDERWENT AN OPEN COLECTOMY AND LAPAROSCOPIC ILEOCOLIC RESECTION PROCEDURE ON (B)(6) 2024 DURING WHICH A TRIMMED PHASIX MESH WAS PLACED IN AN ONLAY FASHION AND SUTURED USING ABSORBABLE MONOFILAMENT 2.0 PDS SUTURES. A 3 CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. ON (B)(6) 2024, THE PATIENT WAS TAKEN BACK FOR INCISIONAL HEMATOMA EVACUATED. THE SUBJECT PATIENT WAS DISCHARGED ON (B)(6) 2024. ON (B)(6) 2024, SUBJECT PATIENT WAS DIAGNOSED WITH SWELLING DUE TO FLUID NOTED AT INCISION SITE WHICH WAS RECURRENT INCISIONAL HEMATOMA REQUIRING DRAINAGE AND WAS DISCHARGED WITH DRAINS PLACED ON (B)(6) 2024. THE REPORTED ADVERSE EVENT (RECURRENT INCISIONAL HEMATOMA) HAS BEEN ASSESSED PER CLINICIAN AS PROBABLY RELATED TO THE STUDY DEVICE AND A CAUSAL RELATIONSHIP TO THE PROCEDURE AND RECOVERING/RESOLVING. THE AE HAS BEEN ASSESSED AS SEVERE IN SEVERITY. THE REPORTED AE DOES MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).

  Patient problems: Hematoma

  MAUDE report 21112775 ↗
• InjuryJan 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT UNDERWENT OPEN AND LAPAROSCOPIC COLECTOMY PROCEDURE ON (B)(6) 2024 DURING WHICH A TRIMMED PHASIX MESH WAS PLACED IN AN ONLAY FASHION AND SUTURED USING ABSORBABLE MONOFILAMENT 2.0 PDS SUTURES. A 3 CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT HAS BEEN DIAGNOSED WITH INCISIONAL ABSCESS REQUIRING DRAINAGE. THE SUBJECT PATIENT WAS READMITTED FOR PERIUMBILICAL ERYTHEMA AND PAIN WITH CT DEMONSTRATING SUBCUTANEOUS FLUID COLLECTION CONCERNING SEROMA THEREFORE IR DRAIN PLACED ON (B)(6) 2024 AND PROVIDED ANTIBIOTICS (IV VANCOMYCIN AND CLINDAMYCIN). PATIENT WAS HOSPITALIZED. THE REPORTED ADVERSE EVENT (INCISIONAL ABSCESS) HAS BEEN ASSESSED PER CLINICIAN AS PROBABLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE AE HAS BEEN ASSESSED AS MODERATE IN SEVERITY. THE REPORTED AE DOES MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).

  Patient problems: Abdominal Pain; Abscess; Seroma

  MAUDE report 21111311 ↗
• InjuryJun 30, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  AS REPORTED PER CLINICAL TRIAL DVL-HE-018: ON (B)(6) 2021, THE SUBJECT PATIENT UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC, LAPAROTOMY, COLECTOMY PROCEDURE IN INFRAUMBILICAL LOCATION. A PHASIX MESH WAS TRIMMED AND PLACED IN ONLAY FASHION AND FIXATED USING ABSORBABLE MONOFILAMENT SUTURES WITH 14 FIXATION POINTS. THE PATIENT DISCHARGE FROM THE HOSPITAL ON (B)(6) 2021. FROM (B)(6) 2022 TO (B)(6) 2023 PATIENT EXPERIENCED MULTIPLE ADVERSE EVENTS AND VISITED THE HOSPITAL MULTIPLE TIMES, ALL THE ADVERSE EVENTS REPORTED DURING THIS PERIOD WERE NOT RELATED TO THE STUDY DEVICE. ON (B)(6) 2023 THE SUBJECT PATIENT EXPERIENCED ABDOMINAL PAIN. THE ADVERSE EVENT OF ABDOMINAL PAIN HAS BEEN ASSESSED PER CLINICIAN AS MILD IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE, POSSIBLY RELATED TO THE PROCEDURE, AND RECOVERED/RESOLVED. THE REPORTED ADVERSE EVENT DOES NOT MEET THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE UADE (UNANTICIPATED ADVERSE DEVICE EFFECT).

  Patient problems: Abdominal Pain

  MAUDE report 17238586 ↗
• MalfunctionOct 6, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL STUDY ((B)(4)): ON (B)(6) 2021, THE SUBJECT PATIENT UNDERWENT PRIMARY LAPAROSCOPIC COLECTOMY PROCEDURE, DURING WHICH A PHASIX MESH RECTANGLE (8X20CM) WAS TRIMMED AND PLACED IN ONLAY FASHION USING PDS SUTURE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2021. THE SUBJECT PATIENT WAS DIAGNOSED WITH SCAR TISSUE FORMATION AND NO ACTION WAS TAKEN. THE AE IS CLINICALLY ASSESSED TO BE OF MILD SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE, POSSIBLY RELATED TO PROCEDURE AND RECOVERED/RESOLVED WITH SEQUELAE. THE REPORTED ADVERSE EVENT DOES NOT MEET THE UADE (UNANTICIPATED ADVERSE DEVICE EFFECT).

  Patient problems: Scar Tissue

  MAUDE report 15554190 ↗
• MalfunctionApr 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED IN (B)(4): ON (B)(6) 2021, THE PATIENT UNDERWENT A LAPAROSCOPIC COLECTOMY AND A BARD/DAVOL PHASIX MESH WAS TRIMMED AND PLACED IN ONLAY FASHION. THE MESH WAS SUTURED IN PLACE WITH NON-BARD/DAVOL ABSORBABLE MONOFILAMENT SUTURES AND A BARD/DAVOL SORBAFIX FIXATION DEVICE. ON (B)(6) 2021, THE PATIENT WAS DIAGNOSED WITH SUPERFICIAL WOUND DEHISCENCE. THIS AE IS REPORTED TO HAVE RESOLVED WITH NO TREATMENT PROVIDED, ON (B)(6) 2021. IT WAS ALSO REPORTED THAT THE PATIENT HAD PAIN ASSOCIATED WITH SKIN DEHISCENCE. UPON INSPECTION IT APPEARED THAT THE STITCHES HAD "POPPED OPEN" IN A SMALL SECTION OF INCISION. STUDY CLINICIAN NOTED NO CONCERNS AND HEALING WAS GOING WELL STILL. THE ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE 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 DEFINITELY RELATED TO THE INDEX PROCEDURE. THE ADVERSE EVENT HAS BEEN ASSESSED PER CEC CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 14140601 ↗
• MalfunctionApr 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER PREVENT CLINICAL TRIAL (B)(6): ON (B)(6) 2021, THE PATIENT UNDERWENT A LAPAROSCOPIC COLECTOMY AND A BARD/DAVOL PHASIX MESH WAS TRIMMED AND PLACED IN ONLAY FASHION WITH 3 CM OVERLAP IN ALL DIRECTIONS. THE MESH WAS SUTURED WITH NON-BARD/DAVOL ABSORBABLE MONOFILAMENT SUTURES AND A BARD/DAVOL SORBAFIX FIXATION DEVICE. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT WAS DIAGNOSED WITH POSTOPERATIVE SEROMA. THE SEROMA IS REPORTED TO HAVE RESOLVED WITH NO TREATMENT PROVIDED, ON (B)(6) 2021. 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 DEFINITELY RELATED TO THE INDEX PROCEDURE. THE ADVERSE EVENT HAS BEEN ASSESSED PER CEC CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE.

  Patient problems: Seroma

  MAUDE report 14140591 ↗
• InjuryApr 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER PREVENT CLINICAL TRIAL (B)(4): ON (B)(6) 2020, PATIENT UNDERWENT A LAPAROSCOPIC LOW ANTERIOR COLON RESECTION. A BARD/DAVOL PHASIX MESH WAS TRIMMED AND PLACED IN ONLAY FASHION. A 3CM OVERLAP WAS ACHIEVED IN ALL DIRECTIONS. THE MESH WAS SUTURED IN PLACE WITH 1 PDS ABSORBABLE MONOFILAMENT SUTURE AND SORBAFIX FIXATION. ON (B)(6) 2020, THE PATIENT WAS DIAGNOSED WITH INCISIONAL PAIN. PAIN MEDICATION WAS PROVIDED FOR PAIN MANAGEMENT AND THE PAIN RESOLVED ON (B)(6) 2022. THE ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, AND AS NOT A SERIOUS ADVERSE EVENT (SAE) OR AN UNANTICIPATED ADVERSE DEVICE EFFECT (UADE), PER STUDY GROUP. THE ADVERSE EVENT HAS BEEN ASSESSED PER THE STUDY CLINICIAN AS NOT RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE ADVERSE EVENT HAS BEEN ASSESSED PER CEC CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE.

  Patient problems: Pain

  MAUDE report 14113192 ↗