Phasix 1190603Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741010637), received between Nov 10, 2017 and Mar 25, 2026 — classified as 4 injuries.

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

• InjuryMar 25, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2018, PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX LIGHT MESH (DEVICE 1- RIGHT) AND 3DMAX MESH (DEVICE 2- LEFT). PER OPERATIVE NOTES, ¿IN THE RIGHT INGUINAL AREA, THE LOOP OF COLON ADHERENT TO THE PREPERITONEUM WAS FREED. A TWO VERY LARGE HERNIA DEFECTS, INDIRECT AND DIRECT DEFECT WAS CLEARED OFF THE PREPERITONEAL SPACE AND 3DMAX LIGHT MESH (DEVICE 1- RIGHT) WAS PLACED IN PREPERITONEAL SPACE AND SECURED WITH SUTURES. TO THE LEFT SIDE, AN INDIRECT DEFECT WAS REDUCED AND SECURED MEDIALLY WITH SUTURES SUPERIORLY. FLAPS WERE RAISED AND 3DMAX MESH (DEVICE 2-LEFT) WAS PLACED OVER THE DEFECT AND SECURED WITH SUTURES.¿ ON (B)(6) 2018, PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA AND GROIN PAIN THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿THROUGH THE PRIOR INCISION, THE PRIOR MESH (DEVICE 1) WAS NOTED. THE CONTENTS OF THE HERNIA WAS REDUCED BACK INTO THE ABDOMEN. A PIECE OF SYNTHETIC MESH WAS PLACED INTO THE SPACE POSTERIOR TO THE MESH (DEVICE 1) AND SUTURED AND REAPPROXIMATED TO NEW SYNTHETIC M

  Patient problems: Hernia

  MAUDE report 24687841 ↗
• InjuryJun 28, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL MESH PLUG PHASIX ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE MESH PLUG PHASIX. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 14839300 ↗
• InjurySep 27, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2015 - PATIENT UNDERWENT AN INCARCERATED RIGHT INGUINAL HERNIA REPAIR PROCEDURE TO INTRODUCE A BARD/DAVOL PHASIX PLUG AND PATCH TO PATIENT'S PERITONEAL CAVITY TO REINFORCE TISSUE AFFECTED BY THE HERNIA. ON (B)(6) 2016: THE PATIENT UNDERWENT A SUBSEQUENT SURGERY TO REPAIR AN UMBILICAL HERNIA. THE PATIENT WAS IMPLANTED WITH A NON-BARD/DAVOL MESH. THE ATTORNEY ALLEGES THE PATIENT HAS EXPERIENCED AND CONTINUES TO EXPERIENCE STOMACH PAIN SINCE THE MULTIPLE PROCEDURES AND HERNIA MESH IMPLANTS. THE PATIENT LIVES IN CONSTANT FEAR THAT WHENEVER SHE SNEEZES OR COUGHS, THE MESH WILL TEAR, OR A NEW HERNIA WILL EMERGE. ADDITIONALLY, PATIENT IS CHALLENGED WITH HER NOW LIMITED RANGE OF MOTION AND PERFORMING DAILY ACTIVITIES. THESE INJURIES AND INABILITIES WERE NOT PRESENT BEFORE THE IMPLANTATION OF THE MESH PRODUCTS. THE PATIENT HAS SUFFERED SEVERE AND POSSIBLY PERMANENT INJURIES, AND EMOTIONAL DISTRESS. PATIENT HAS ALSO ENDURED AND CONTINUES TO SUFFER THE MENTAL ANGUISH AND PSYCHOLOGICAL TRAUMA OF LIVING WITH THESE DEFECTIVE PRODUCTS IMPLANTED IN HER BODY.

  Patient problems: Disability; Injury; Pain

  MAUDE report 7915982 ↗
• InjuryNov 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO DAVOL: ON (B)(6) 2013 - THE PATIENT UNDERWENT THE REPAIR OF A SUPRAUMBILICAL HERNIA (MULTIPLE) AND WAS IMPLANTED WITH A BARD MESH (VENTRALEX). PER THE PATIENT, TWO SMALL HERNIAS WERE COMBINED AND REPAIRED WITH THE ONE MESH ON (B)(6) 2017 - THE PATIENT HAD BEEN DIAGNOSED WITH FOUR HERNIAS IN THE AREA OF THE PREVIOUS REPAIR. THE PATIENT UNDERWENT REPAIR OF THE HERNIA AND AS REPORTED THE ONLAY (PATCH) PORTION OF A BARD PHASIX PLUG AND PATCH WAS USED TO REPAIR THE DEFECTS. THE ONLAY WAS FIXATED IN PLACE WITH A NON BARD/DAVOL FIXATION DEVICE. THE CONTACT REPORTS THAT THERE IS NO INDICATION IN THE INFORMATION RECEIVED THAT THE PREVIOUSLY IMPLANTED BARD MESH WAS EXPLANTED. THE CONTACT REPORTS THAT THE PATIENT EXPERIENCED HOSPITAL ACQUIRED PNEUMONIA DURING THE HOSPITAL STAY, AS WELL AS SEVERE EDEMA IN HIS FEET AS HIS DIURETIC WAS STOPPED UPON ADMISSION DUE TO DEHYDRATION. THE CONTACT STATES THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TOO SOON, WHEN THE POSTOPERATIVE ISSUES HE WAS EXPERIENCING "SUDDENLY RESOLVED" PER THE DOCTOR. ON (B)(6) 2017 - THE PATIENT RETURNED TO THE HOSPITAL DUE TO PAIN AND REDNESS AROUND THE SURGICAL INCISION. THE PATIENT WAS ASSESSED

  Patient problems: Bacterial Infection; Pain; Unspecified Infection

  MAUDE report 7019077 ↗