Phasix 1200015Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741095290), received between Apr 4, 2018 and Nov 21, 2024 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A VENTRAL HERNIA REPAIR WITH TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), THE PATIENT WAS IMPLANTED WITH PHASIX ST ON (B)(6) 2021. IT WAS REPORTED THAT IN (B)(6) 2024 THE PATIENT RETURNED WITH RECURRENT OBSTRUCTED HERNIA, SEVERE ADHESIONS AND FOUND THAT THE MESH HAS NOT COMPLETELY ABSORBED IN 37 MONTHS. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT TRANSVERSUS ABDOMINIS RELEASE (TAR) FOR RECURRENT OBSTRUCTED HERNIA AND PATIENT IS RECOVERING.

  Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion

  MAUDE report 20744167 ↗
• InjuryNov 13, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2024 THE PATIENT WAS IMPLANTED WITH A PHASIX ST MESH. REPORTEDLY ON (B)(6) 2024 THE PATIENT WAS DIAGNOSED WITH A POST OPERATIVE INFECTION ¿WHERE THE MESH ALSO GOT INFECTED¿ AND IS UNDERGOING ANTIBIOTICS TREATMENT. IT IS REPORTED THAT THERE IS A PLAN TO EXPLANT THE MESH, HOWEVER A DATE WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 20672579 ↗
• MalfunctionAug 3, 2023Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING A PROCEDURE ON (B)(6) 2023, AN EXPIRED PHASIX ST WAS INADVERTENTLY IMPLANTED INTO THE PATIENT. THE LABELED EXPIRATION DATE OF THE IMPLANT IS (B)(6) 2022. THERE WAS NO ADDITIONAL MEDICAL TREATMENT PROVIDED AND THE SURGEON HAS NO CONCERN FOR ADDITIONAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17449667 ↗
• InjuryOct 31, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A HERNIA RECURRENCE. ON (B)(6) 2017 THE SUBJECT PATIENT UNDERWENT A LAPAROSCOPIC REPAIR OF AN UMBILICAL HERNIA. BOTH SUTURE AND MECHANICAL FIXATION WERE USED TO FIXATE THE MESH. AN INTRA-ABDOMINAL SURGICAL TECHNIQUE WAS USED. THE HERNIA MEASURED 5CM IN LENGTH AND 4CM IN WIDTH. THE PHASIX ST MESH WAS NOT TRIMMED AND WAS POSITIONED SO THAT ITS EDGES EXTENDED BEYOND THE MARGINS OF THE DEFECT BY AT LEAST 5CM. ON (B)(6) 2019 THE SUBJECT PATIENT WAS DIAGNOSED WITH A HERNIA RECURRENCE. THIS HERNIA HAS BEEN ASSESSED PER THE CLINICIAN AS MILD IN SEVERITY WITH NO ACTION TAKEN AT THIS TIME. THE AE HAS BEEN ASSESSED AS POSSIBLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE INDEX PROCEDURE.

  Patient problems: Hernia

  MAUDE report 9260913 ↗
• InjuryJun 18, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING IS BASED ON MEDICAL RECORDS: (B)(6) 2017 - THE PATIENT WAS DIAGNOSED WITH A UNILATERAL INGUINAL HERNIA, UMBILICAL HERNIA, LIPODYSTROPHY AND UNDERWENT REPAIR OF MULTIPLE ABDOMINAL HERNIAS, ABDOMINOPLASTY AND LIPOSUCTION. DURING THIS PROCEDURE THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL PHASIX ST MESH. ON (B)(6) 2017 - THE PATIENT HAD FOLLOW UP OFFICE VISIT WITH COMPLAINTS OF RIGHT GROIN PAIN. ON (B)(6) 2017, (B)(6) 2017 - THE PATIENT UNDERWENT AN ULTRASOUND GUIDED, LEFT ANTERIOR ABDOMINAL WALL SUBCUTANEOUS SEROMA ASPIRATION PROCEDURE. ON (B)(6) 2017 - THE PATIENT WAS DIAGNOSED WITH AN INFECTION AND INFLAMMATORY REACTION DUE TO THE MESH (PHASIX ST) IMPLANT AND UNDERWENT AN ULTRASOUND GUIDED, LEFT ANTERIOR ABDOMINAL WALL SUBCUTANEOUS SEROMA ASPIRATION PROCEDURE. ON (B)(6) 2017 - THE PATIENT UNDERWENT AN ABDOMINAL WALL EXPLORATION WITH REMOVAL OF THE BARD/DAVOL PHASIX ST MESH WITH A POST OPERATIVE SURGICAL DRAIN PLACED. THE FOLLOWING WAS REPORTED BY THE CONTACT: THE PATIENT CURRENTLY WORKS OUT REGULARLY; HOWEVER, IS HAVING DIFFICULTY WITH ABDOMINAL EXERCISING AND STRENGTHENING AND HAS BEEN EXPERIENCING A LOT OF SWELLING AND SORENESS IN THE AREA OF HER VENTRAL HERNIA REPAI

  Patient problems: Inflammation; Seroma; Unspecified Infection

  MAUDE report 8709643 ↗
• InjuryApr 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A HERNIA RECURRENCE. (B)(6) 2017 - THE SUBJECT PATIENT UNDERWENT A LAPAROSCOPIC UMBILICAL/EPIGASTRIC HERNIA REPAIR WITH IMPLANT OF THE PHASIX ST MESH. A CONCOMITANT PARTIAL OMENTAL RESECTION PROCEDURE WAS ALSO PERFORMED AT THIS TIME. AN INTRA-ABDOMINAL TECHNIQUE WAS USED. AS REPORTED PER CRF, THE PHASIX MESH WAS POSITIONED SO THAT ITS EDGES EXTEND BEYOND THE MARGINS OF THE DEFECT BY AT LEAST 5CM. MECHANICAL FIXATION WITH A NON BARD/DAVOL SECURESTRAP DEVICE WAS USED TO SECURE THE MESH. (B)(6) 2019 - THE PATIENT PRESENTED FOR THE 24 MONTH VISIT AND UNDERWENT A CT SCAN THAT REVEALED A HERNIA RECURRENCE WITHIN 5CM OF THE INDEX HERNIA REPAIR. THIS HERNIA RECURRENCE HAS BEEN ASSESSED PER THE CLINICIAN AS BEING OF MODERATE SEVERITY, "DEFINITELY RELATED" TO THE STUDY DEVICE AND "DEFINITELY RELATED" TO THE INDEX PROCEDURE. AS REPORTED, THE ADVERSE EVENT WILL REQUIRE MEDICAL/SURGICAL INTERVENTION. THERE IS NO DATE SET FOR RE-OPERATION AT THIS TIME.

  Patient problems: Hernia

  MAUDE report 8515357 ↗
• InjuryJan 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY ((B)(6) CLINICAL STUDY (B)(6)) EXPERIENCED A HERNIA RECURRENCE. ON (B)(6) 2017 - THE STUDY PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR AND WAS IMPLANTED WITH A BARD PHASIX ST MESH. ON (B)(6) 2018 - THE STUDY PATIENT UNDERWENT NISSAN FUNDOPLICATION. THE SURGEON NOTES THAT DURING THIS PROCEDURE HE DID NOT TOUCH OR ALTER THE STUDY MESH IN ANY WAY WHEN HE WAS IN THE AREA FOR THE NISSEN FUNDOPLICATION. ON (B)(6) 2018 - THE STUDY PATIENT PRESENTED FOR A 12 MONTH FOLLOW UP VISIT FOR THE HERNIA REPAIR. AS NOTED THERE WERE NO COMPLICATIONS WITH THE HERNIA REPAIR. ON (B)(6) 2018 - THE STUDY PATIENT PRESENTED FOR A POSTOPERATIVE VISIT FOLLOWING THE NISSEN FUNDOPLICATION AND REPORTED THAT HER "INCISIONAL HERNIA POPPED OPEN 2 WEEKS AGO." UPON PHYSICAL EXAM THE SURGEON NOTES THE PREVIOUS INCISION TO BE CLEAN/DRY/INTACT AND THERE IS A RECURRENT UPPER MIDLINE HERNIA ABOUT 5 CM IN SIZE. HE DID NOT FEEL IT WAS NECESSARY TO CONFIRM THIS RECURRENCE WITH A CT SCAN AS IT IS "OBVIOUSLY A HERNIA RECURRENCE AT THE SITE OF THE STUDY MESH." THE HERNIA RECURRENCE HAS BEEN ASSESSED BY THE CLINICIAN AS DEFINITELY RELATED TO THE

  Patient problems: Adhesion(s); Hernia

  MAUDE report 8213819 ↗
• InjuryOct 17, 2018Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information; Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF THE PHASIX ST STUDY (B)(4), EXPERIENCED A HERNIA RECURRENCE. (B)(6) 2016 - THE SUBJECT PATIENT UNDERWENT A ROBOTIC ASSISTED UMBILICAL HERNIA REPAIR WITH IMPLANT OF THE PHASIX ST MESH. THE TECHNIQUE WAS PERFORMED INTRA-ABDOMINALLY. THE PHASIX ST MESH IS REPORTED TO HAVE BEEN POSITIONED SO THAT ITS EDGES EXTEND BEYOND THE MARGINS OF THE DEFECT BY AT LEAST 5CM. THE MESH WAS FIXED WITH ABSORBABLE MONOFILAMENT SUTURE. (B)(6) 2018 -THE SUBJECT PATIENT UNDERWENT A CT SCAN IN WHICH A HERNIA RECURRENCE WAS NOTED. THE HERNIA RECURRENCE IS ASSESSED TO BE WITHIN 5CM OF THE INDEX HERNIA REPAIR. THE HERNIA RECURRENCE HAS BEEN ASSESSED BY THE CLINICIAN AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE INDEX PROCEDURE. NO INTERVENTION HAS BEEN REPORTED AT THIS TIME, CONDITION IS LISTED AS ONGOING.

  Patient problems: Hernia

  MAUDE report 7973651 ↗
• InjuryOct 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY (PHASIX ST CLINICAL STUDY (B)(6)) EXPERIENCED A HERNIA RECURRENCE. (B)(6) 2017 - THE SUBJECT PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF A VENTRAL UMBILICAL HERNIA WITH IMPLANT OF THE PHASIX ST MESH. MECHANICAL FIXATION WAS USED. THE PHASIX ST MESH WAS POSITIONED UPON IMPLANT SO THAT ITS EDGES EXTEND BEYOND THE MARGINS OF THE DEFECT BY AT LEAST 5CM. (B)(6) 2018 - THE SUBJECT PATIENT PRESENTED FOR 18 MONTH FOLLOW UP. UPON PHYSICAL EXAM, A HERNIA RECURRENCE WAS NOTED. THE HERNIA IS DOCUMENTED TO BE WITHIN 5CM OF THE INDEX HERNIA REPAIR. THIS RECURRENCE IS ASSESSED BY THE CLINICIAN TO BE MILD IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. AS REPORTED INTERVENTION IS REQUIRED, HOWEVER A REVISION DATE HAS NOT BEEN SCHEDULED AT THIS TIME.

  Patient problems: Hernia

  MAUDE report 7930137 ↗
• InjurySep 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY (PHASIX ST CLINICAL STUDY DVL-HE-017) EXPERIENCED A HERNIA RECURRENCE. ON (B)(6) 2016 - THE SUBJECT PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF AN UMBILICAL HERNIA WITH IMPLANT OF THE PHASIX ST MESH. INTRA-ABDOMINAL TECHNIQUE WAS USED. MECHANICAL FIXATION WAS USED TO FIXATE THE MESH. ON (B)(6) 2018 - THE SUBJECT PATIENT WAS DIAGNOSED WITH A HERNIA RECURRENCE VIA CT SCAN. HERNIA NOTED TO BE REDUCIBLE THIS RECURRENCE IS ASSESSED BY THE CLINICIAN TO BE MODERATE IN SEVERITY AND NOT A SERIOUS ADVERSE EVENT, DEFINITELY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE INDEX PROCEDURE. AS REPORTED INTERVENTION IS REQUIRED, HOWEVER A REVISION DATE HAS NOT BEEN SCHEDULED AT THIS TIME.

  Patient problems: Hernia

  MAUDE report 7848124 ↗
• InjuryAug 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A HERNIA RECURRENCE. ON (B)(6) 2017 - THE PATIENT UNDERWENT A LAPAROSCOPIC, INTRA-ABDOMINAL HERNIA REPAIR AND WAS IMPLANTED WITH A PHASIX ST MESH. THE PHASIX ST IS NOTED TO HAVE BEEN POSITIONED SO THAT ITS EDGES EXTEND BEYOND THE MARGINS OF THE DEFECT BY AT LEAST 5CM. ON (B)(6) 2018 - THE PATIENT WAS REPORTED TO HAVE HAD LOW QUADRANT ABDOMINAL PAIN. ON (B)(6) 2018 - THE PATIENT PRESENTED FOR HIS 18 MONTH FOLLOW UP VISIT. A HERNIA RECURRENCE WAS CONFIRMED UPON PHYSICAL EXAM. THIS ADVERSE EVENT WAS ASSESSED PER THE CLINICIAN AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THE ADVERSE EVENT IS IDENTIFIED AS NOT RECOVERED / NOT RESOLVED. NO INTERVENTION HAS BEEN TAKEN AT THIS TIME.

  Patient problems: Abdominal Pain; Hernia; Pain

  MAUDE report 7747252 ↗
• InjuryJun 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A HERNIA RECURRENCE. ON (B)(6) 2016: THE SUBJECT PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR WITH IMPLANT OF THE PHASIX ST MESH. ON (B)(6) 2018: THE PATIENT WAS DIAGNOSED WITH A HERNIA RECURRENCE. THIS HERNIA RECURRENCE WAS CONFIRMED VIA ULTRASOUND AND HAS BEEN ASSESSED BY THE CLINICIAN AS MILD IN SEVERITY, DEFINITELY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE PROCEDURE. IT IS REPORTED THE SUBJECT PATIENT WILL UNDERGO A REOPERATION.

  Patient problems: Abdominal Pain; Hernia

  MAUDE report 7643270 ↗
• InjuryJun 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A HERNIA RECURRENCE. ON (B)(6) 2016: THE PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR WITH IMPLANT OF THE PHASIX ST MESH. ON (B)(6) 2018: THE PATIENT WAS DIAGNOSED WITH A HERNIA RECURRENCE CONFIRMED WITH IMAGING STUDIES. THE HERNIA RECURRENCE HAS BEEN ASSESSED BY THE CLINICIAN AS MODERATE IN SEVERITY, DEFINITELY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE PROCEDURE. AS REPORTED, REOPERATION WILL BE PERFORMED.

  Patient problems: Hernia

  MAUDE report 7643260 ↗
• InjuryMay 16, 2018Migration or Expulsion of Device; Insufficient Device Problem Information; Migration or Expulsion of Device; Insufficient Device Problem Information

  AS PREVIOUSLY REPORTED ON 05/16/2018. IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A HERNIA RECURRENCE. ON (B)(6) 2016 - THE PATIENT UNDERWENT THE LAPAROSCOPIC REPAIR OF A PRIMARY INCISIONAL HERNIA AND WAS IMPLANTED WITH A DAVOL PHASIX ST MESH. THE MESH WAS FIXATED WITH NON DAVOL FIXATION AND THE MESH WAS POSITIONED SO THAT THE EDGES EXTENDED AT LEAST 5CM BEYOND THE MARGINS OF THE DEFECT. ON (B)(6) 2018 - THE PATIENT PRESENTED FOR 18 MONTH FOLLOW UP AND WAS DIAGNOSED WITH A HERNIA RECURRENCE ON EXAM. A REVISION PROCEDURE HAS BEEN SCHEDULED FOR (B)(6) 2018 DURING WHICH IT IS REPORTED THAT THE PHASIX ST MESH WILL NOT BE REMOVED. AS REPORTED THE PATIENT HAS EXPERIENCED A 24LB WEIGHT GAIN HAS SINCE THE IMPLANT PROCEDURE. THE SEVERITY OF THE AE HAS BEEN ASSESSED AS SEVERE AND DEFINITELY RELATED TO THE DEVICE AND POSSIBLE RELATED TO THE PROCEDURE. ADDENDUM: ON (B)(6) 2018 - THE PATIENT UNDERWENT A PROCEDURE TO REPAIR THE PREVIOUSLY REPORTED RECURRENT HERNIA. A LAPAROSCOPIC ASSISTED RECURRENT VENTRAL HERNIA REPAIR WAS PERFORMED AND THE PATIENT WAS IMPLANTED WITH AN UNSPECIFIED MESH DEVICE. OPERATIVE DICTATION INDICATES THE PHASIX ST MESH WAS NOTED TO

  Patient problems: Hernia

  MAUDE report 7520197 ↗
• InjuryMay 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WHO IS PART OF A CLINICAL STUDY WAS TREATED FOR POSTOPERATIVE PAIN. ON (B)(6) 2017 - THE PATIENT UNDERWENT THE LAPAROSCOPIC REPAIR OF AN UMBILICAL HERNIA. DURING THE PROCEDURE THE PATIENT WAS IMPLANTED WITH A DAVOL PHASTIX ST MESH WHICH WAS FIXATED WITH MECHANICAL FIXATION. ON (B)(6) 2017 - THE PATIENT REPORTED POSTOPERATIVE ABDOMINAL PAIN AND WAS TREATED WITH A PRESCRIPTION FOR PAIN MEDICATION. ON (B)(6) 2017 - THE PATIENT'S CONDITION HAS RESOLVED. THE AE OF POSTOPERATIVE PAIN IS ASSESSED BY THE CLINICIAN TO BE MILD IN SEVERITY, DEFINITELY PROCEDURE RELATED AND POSSIBLE DEVICE RELATED.

  Patient problems: Pain

  MAUDE report 7503557 ↗
• InjuryApr 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY EXPERIENCED A HERNIA RECURRENCE. ON (B)(6) 2016 - THE PATIENT UNDERWENT A LAPAROSCOPIC REPAIR OF AN UMBILICAL HERNIA AND WAS IMPLANTED WITH A DAVOL PHASIX ST MESH. AS REPORTED THE MESH WAS PLACED WITH AT LEASE A 5CM EXTENSION BEYOND THE EDGES OF THE DEFECT. ON (B)(6) 2018 - THE PATIENT WAS DIAGNOSED UPON PHYSICAL EXAM TO HAVE A RECURRENT HERNIA. THE PATIENT IS NOT EXPERIENCING ANY PAIN. THE ADVERSE EVENT (HERNIA RECURRENCE) HAS BEEN ASSESSED AS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. AS REPORTED SURGICAL INTERVENTION IS NEEDED TO THE REPAIR THE RECURRENT HERNIA. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME.

  Patient problems: Hernia

  MAUDE report 7396225 ↗