Phasix 1200008Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741095276), received between Sep 3, 2020 and Mar 23, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryMar 23, 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 PHASIX ST MESH ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD PHASIX ST MESH. 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 13863194 ↗
• InjuryJan 24, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALIGHT ST AND PHASIX ST ON (B)(6) 2020 AND/OR (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH DEVICES. 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: Adhesion(s); Hernia; Insufficient Information; Obstruction/Occlusion; Pain

  MAUDE report 13334354 ↗
• InjurySep 9, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY PRESENTED WITH A SEROMA: ON (B)(6) 2019: SUBJECT PATIENT UNDERWENT ROBOTIC-ASSISTED INTRA-ABDOMINAL REPAIR OF A PRIMARY VENTRAL MIDLINE HERNIA USING A CIRCLE PHASIX ST MESH 8CM (3 IN). THE TOTAL AREA OF THE DEFECT IS REPORTED TO BE 6 CM2. 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. ABSORBABLE MONOFILAMENT SUTURE (QUILL) WAS USED AS THE METHOD OF PERIMETER FIXATION. ABSORBABLE SUTURES (VICRYL) WERE PLACED APPROXIMATELY 2CM APART AND THE FASCIA WAS COMPLETELY REAPPROXIMATED USING A INTERRUPTED STITCH. SKIN CLOSURE WAS ATTEMPTED WITH ADHESIVE SKIN CLOSURE. THE PATIENT WAS PRESCRIBED WITH PROPHYLACTIC ANTIBIOTICS PERI-OPERATIVELY. THERE WERE NO INFECTIONS, FISTULAS OR SWISS CHEESE CONFIGURATIONS PRESENT AT THE TIME OF IMPLANT. THERE WAS A REPORTED PRESENCE OF A "LUMP" SINCE SURGERY. ON (B)(6) 2019: THE PATIENT HAD A FOLLOW UP VISIT DURING WHICH THE PRESENCE OF LUMP WAS NOTED AND DETERMINED TO BE A SEROMA. THE PHYSICIAN PERFORMED AN ASPIRATION (5CC). NO ADDITIONAL MEDICAL OR SURGICAL TREATMENT WAS PROVIDED. THE AE (ADVERSE EVENT)

  Patient problems: Seroma

  MAUDE report 10511358 ↗
• InjurySep 9, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO DAVOL THAT A PATIENT WHO IS PART OF A CLINICAL STUDY PRESENTED WITH A POSTOPERATIVE SEROMA. THE SUBJECT PATIENT UNDERWENT A PRIMARY MIDLINE UMBILICAL INCISIONAL HERNIA REPAIR VIA A ROBOTIC ASSISTED PROCEDURE USING INTRA-ABDOMINAL SURGICAL TECHNIQUE AND WAS IMPLANTED WITH AN 8CM (3 IN) CIRCLE PHASIX ST MESH. A MINIMUM OF 5CM OVERLAP WAS ACHIEVED IN ALL DIRECTIONS OF THE INCISION SITE (CLASS I, CLEAN WOUND). PERIMETER FIXATION OF THE MESH WAS ACHIEVED BY USING SUTURES. THE PATIENT WAS PRESCRIBED WITH PROPHYLACTIC ANTIBIOTICS PERIOPERATIVELY. DURING A FOLLOW UP VISIT ON (B)(6) 2019, THE PATIENT PRESENTED WITH SEROMA. THE SEROMA WAS ASSESSED BY THE CLINICIAN TO BE OF MODERATE SEVERITY, "LIKELY RELATED" TO THE STUDY DEVICE AND "LIKELY RELATED" TO THE INDEX PROCEDURE. THE SEROMA WAS INDICATED TO BE RESOLVING. THE PATIENT DEFERRED MEDICAL/SURGICAL INTERVENTION AT THIS TIME AND WILL BE SCHEDULED FOR SURGERY AT A FUTURE DATE. THE PATIENT WAS ADVISED TO FOLLOW UP IF THE SEROMA BECOMES SYMPTOMATIC.

  Patient problems: Seroma

  MAUDE report 10508037 ↗
• InjurySep 3, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED AND IS ASSOCIATED WITH PHASIX ST STUDY (B)(6): ON (B)(6) 2018: THE STUDY PATIENT UNDERWENT THE REPAIR OF AN INCARCERATED HERNIA NEAR THE UMBILICUS AND A SECOND INCARCERATED HERNIA LOCATED IN THE EPIGASTRIUM PERFORMED VIA ROBOTIC ASSISTED APPROACH. AN 8CM CIRCLE PHASIX ST WAS USED IN THIS REPAIR. ON (B)(6) 2018: THE STUDY PATIENT EXPERIENCED A POST-OPERATIVE SEROMA. THE SEROMA WAS DRAINED DURING A POSTOPERATIVE FOLLOW-UP. NO FURTHER ACTION WAS TAKEN. ON (B)(6) 2018: SEROMA IS NOTED TO HAVE RESOLVED. THE SEROMA WAS ASSESSED PER THE CLINICAL PI TO BE LIKELY RELATED TO THE STUDY DEVICE AND LIKELY RELATED TO THE INDEX PROCEDURE. THE AE HAS BEEN ASSESSED AS MODERATE IN SEVERITY BY THE CLINICIAN. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 10490662 ↗