Phasix 1193045Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741107672), received between Aug 16, 2023 and Jul 31, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Patient-Device Incompatibility; No Apparent Adverse Event

  As reported per Clinical Trial (b)(4):The subject patient underwent an open primary exploratory laparotomy with distal pancreatectomy, splenectomy splenic artery lymphadenectomy, omental flap, liver wedge biopsy as concomitant procedures on (b)(6) 2025, during which the patient was implanted with Phasix Mesh onlay was trimmed and implanted using 3-0 PDS absorbable monofilament suture. The midline fascia was completely closed with slow absorbing monofilament 0 PDS sutures using running stitch. Subject was known to have pancreatic leak from POD 3 drain amylase (1781), sent home with JPs to remove later. The subject was discharged from hospital on (b)(6) 2025.(b)(6) 2026 - The patient was diagnosed with an incisional hernia occurrence. During the 12-month follow-up visit, the Sub-I palpated a 5 x 5 cm hernia on physical examination.As reported, the adverse event (Incisional Hernia Occurrence) has been assessed per clinician (medical monitor) as probably related to the study device, causally related to the procedure and not recovered/not resolved. The AE has been assessed as mild in severity. The reported AE does not meet the definition of a SAE (serious adverse event) and does not mee

  Patient problems: Hernia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50103761 ↗
• InjuryJan 29, 2026Patient-Device Incompatibility

  AS REPORTED PER CLINICAL TRIAL (B)(6): THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 AND UNDERWENT AN OPEN LAPAROSCOPIC PRIMARY LAPAROTOMY COLOSTOMY TAKEDOWN AND SIGMOIDOSCOPY DURING WHICH A PHASIX FLAT MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MULTIFILAMENT SUTURES WITH 2-0 PDS. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH AND THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ETHICON SLOW ABSORBABLE MONOFILAMENT 1 PDS SUTURES. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2025. ON (B)(6) 2026, THE SUBJECT PATIENT DEVELOPED ABDOMINAL PAIN. NO FURTHER ACTION WAS TAKEN. THE REPORTED ADVERSE EVENT (ABDOMINAL PAIN) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY; THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS RECOVERING/RESOLVING. THE REPORTED AES DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

  Patient problems: Abdominal Pain; Obstruction/Occlusion

  MAUDE report 24209953 ↗
• InjuryJul 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER THE CLINICAL TRIAL (B)(4). THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 AND UNDERWENT AN OPEN PRIMARY LAPAROTOMY SMALL BOWEL RESECTION AND OSTOMY CREATION/REVISION/REVERSAL DURING WHICH A PHASIX FLAT MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH MECHANICAL SECURE STRAP. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH AND THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ETHICON SLOW ABSORBING MONOFILAMENT WITH RUNNING STITCHES APPROXIMATELY 0.26 CM FAR APART. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2025. ON (B)(6) 2025, THE SUBJECT PATIENT DEVELOPED ABSCESS UNDER SKIN THAT NEEDED TO BE DRAINED. PATIENT ALSO DEVELOPED FEVER AND NOTICED DISCHARGE COMING FROM INCISION LINE. ABSCESS WAS DRAINED AND PACKED AND PATIENT WAS DISCHARGED FROM HOSPITAL (B)(6) 2025. ABSCESS RESOLVED; PACKING WILL GO ON FOR TWO TO THREE WEEKS. THE REPORTED ADVERSE EVENT (ABSCESS) HAS BEEN ASSESSED PER CLINICIANS AS PROBABLY RELATED TO THE STUDY DEVICE AND CAUSALLY TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY, THE REPORTED ADVERSE EVENT (ABSCESS) HAS BEEN ASSESSED AS RECOVERING/RESOLVING. THE REPORTED AE MEETS THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT

  Patient problems: Abscess; Fever

  MAUDE report 22398023 ↗
• InjuryApr 16, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  AS REPORTED PER THE CLINICAL TRIAL (B)(4): ON (B)(6) 2025 THE SUBJECT PATIENT UNDERWENT AN OPEN EXPLORATORY LAPAROTOMY WITH DISTAL PANCREATECTOMY, SPLENECTOMY SPLENIC ARTERY LYMPHADENECTOMY, OMENTAL FLAP, LIVER WEDGE BIOPSY AS CONCOMITANT PROCEDURES, DURING WHICH THE PATIENT WAS IMPLANTED WITH PHASIX MESH USING 3-0 PDS ABSORBABLE MONOFILAMENT SUTURE. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH SLOW ABSORBING MONOFILAMENT 0 PDS SUTURES USING RUNNING STITCH. SUBJECT PATIENT HAD A PANCREATIC LEAK FROM POD 3 DRAIN AMYLASE AND WAS SENT HOME ON (B)(6) 2025 WITH JPS TO REMOVE LATER. ON (B)(6) 2025 THE PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 WITH FEVER AND UNDERWENT CT IMAGING. IT WAS NOTED THE LUQ DRAIN SITE HAD REDNESS & PURULENT DRAINAGE. ON (B)(6) 2025 THE PATIENT UNDERWENT A CT SCAN SHOWING SOFT TISSUE STRANDING THROUGHOUT THE RIGHT FLANK ENCOMPASSING THE LEFT DRAIN, WHICH MAY REFLECT DEVELOPING CELLULITIS. REDNESS HAD GROWN ON SUBJECT'S SIDE. THE SUBJECT PATIENT'S PAIN WAS MANAGED WITH PO AND IV MEDICATION. AS REPORTED, "ALTHOUGH THE PANCREATIC LEAK IS THE PRIMARY CAUSE OF THE ACUTE ABDOMINAL PAIN IN THIS PATIENT, THE CONTR

  Patient problems: Abdominal Pain

  MAUDE report 21850261 ↗
• MalfunctionAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED PER CLINICAL TRIAL (B)(4): ON (B)(6) 2021, THE SUBJECT PATIENT UNDERWENT AN EXPLORATORY PRIMARY LAPAROTOMY PERFORMED WITH CONCOMITANT APPENDECTOMY, CHOLECYSTECTOMY, RADICAL RIGHT SIDED NEPHRECTOMY (REPAIR OF DIAPHRAGMATIC INJURY) DURING WHICH A PHASIX MESH WAS TRIMMED AND PLACED IN AN ONLAY FASHION. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH CANCER RECURRENCE, AND WAS STARTED ON CHEMOTHERAPY AND UNDERWENT RE-OPERATION ON (B)(6) 2023. THE PATIENT REQUIRED HOSPITAL STAY FOR A PERIOD OF ONE WEEK. THE CANCER RECURRENCE WAS ASSESSED BY THE TREATING CLINICIAN OR THE CLINICAL EVIDENCE REVIEW COMMITTEE TO BE UNRELATED TO THE PHASIX STUDY DEVICE USED IN THE LAPAROTOMY REPAIR.

  Patient problems: Cancer

  MAUDE report 17560138 ↗