Phasix 1201020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741095313), received between Mar 28, 2018 and Apr 11, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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.

• InjuryApr 11, 2023Defective 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 AN UNSPECIFIED BARD/DAVOL PHASIX MESH ON (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST PHASIX 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: Adhesion(s); Hernia; Insufficient Information; Obstruction/Occlusion; Pain

  MAUDE report 16711158 ↗
• InjurySep 4, 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/BOWEL OBSTRUCTION: ON (B)(6) 2017 THE SUBJECT PATIENT UNDERWENT ROBOTIC-ASSISTED REPAIR OF A (FIRST-TIME), INFRAUMBILICAL HERNIA USING THE PHASIX ST MESH. AN INTRA-ABDOMINAL APPROACH WAS USED WITH NO COMPONENT SEPARATION. THE TOTAL HERNIA SIZE IS MEASURED AS 21.2CM (9CML/3CMW). 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 WAS USED AS THE METHOD OF PERIMETER FIXATION WITH 3 FIXATION POINTS. ABSORBABLE SUTURES WERE PLACED APPROX. 2CM APART AND THE FASCIA WAS COMPLETELY RE-APPROXIMATED USING A RUNNING STITCH. SKIN CLOSURE WAS ATTEMPTED WITH BOTH SUTURES AND SURGICAL GLUE. ON (B)(6) 2019 THE SUBJECT PATIENT WAS DIAGNOSED WITH A SMALL BOWEL OBSTRUCTION. ON (B)(6) 2019 THE SUBJECT PATIENT UNDERWENT A CT SCAN WHICH SHOWED EVIDENCE OF A HERNIA RECURRENCE. ON (B)(6) 2019 TO (B)(6) 2019 THE SUBJECT PATIENT WAS HOSPITALIZED AND PLACED ON BOWEL REST. AS REPORTED THE PATIENT DEVELOPED A HERNIA RECURRENCE WHICH LED TO A SMALL BOWEL OBSTRUCTION. PER CLINICIAN, THE REPORTED EVENT

  Patient problems: Hernia; Obstruction/Occlusion

  MAUDE report 8960477 ↗
• InjuryJun 26, 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 ROBOTIC ASSISTED INCISIONAL, UMBILICAL HERNIA REPAIR WITH USE OF THE PHASIX ST MESH. ON (B)(6) 2018: THE PATIENT WAS DIAGNOSED WITH A HERNIA RECURRENCE. THE REPORTED EVENT HAS BEEN ASSESSED BY THE CLINICIAN AS BEING MODERATE IN SEVERITY, DEFINITELY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. AS INDICATED, A REOPERATION IS NOT NEEDED AT THIS TIME.

  Patient problems: Hernia

  MAUDE report 7638444 ↗
• InjuryMay 18, 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 PARTIAL SMALL BOWEL OBSTRUCTION. ON (B)(6) 2017 - THE PATIENT UNDERWENT A ROBOTIC ASSISTED INTRA-ABDOMINAL (RIGHT, LATERAL STOMA SITE) HERNIA REPAIR AND WAS IMPLANTED WITH A DAVOL PHASIX ST MESH. THE MESH WAS FIXATED WITH ABSORBABLE MONOFILAMENT SUTURE AT 3 FIXATION POINTS. THE MESH WAS NOT TRIMMED AND IT EXTENDED BEYOND THE MARGINS OF THE DEFECT BY AT LEAST 5CM. ON (B)(6) 2018 - THE PATIENT WAS HOSPITALIZED WITH A PARTIAL SMALL BOWEL OBSTRUCTION AND WAS GIVEN IVF, COMFORT MEASURES. UPON ADMISSION THE PATIENT'S LACTIC ACID READING WAS 4.8 THE READING DROPPED TO 0.6, THE SMALL BOWEL OBSTRUCTION RESOLVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2018. THE CLINICIAN ASSESSED THE AE AS MILD IN SEVERITY, POSSIBLY DEVICE RELATED AND POSSIBLY PROCEDURE RELATED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 7525152 ↗
• InjuryMar 28, 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. (B)(6) 2016 - THE PATIENT UNDERWENT A ROBOTIC ASSISTED REPAIR OF AN EPIGASTRIC AND UMBILICAL HERNIA USING THE DAVOL PHASIX ST HERNIA MESH. THE HERNIA IS DOCUMENTED TO BE OF SWISS CHEESE CONFIGURATION (MULTIPLE DISCREET HERNIAS). THE MESH WAS PLACED TO EXTEND AT LEAST 5CM BEYOND THE MARGINS OF THE DEFECT. THE OPERATIVE DETAILS NOTE THE PATIENT HAD A WEIGHT LOSS OF 30 LBS IN THE 10 MONTHS PRIOR TO THIS PROCEDURE WHICH CREATED LAXITY OF THE ABDOMINAL WALL AND ABILITY TO PERFORM THE PROCEDURE WITHOUT USING COMPONENT SEPARATION TECHNIQUE. (B)(6) 2016 - THE PATIENT PRESENTED WITH ABDOMINAL TENDERNESS. THIS WAS ASSESSED AS MILD AND POSSIBLY RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. A RESOLUTION DATE OF 06/09/2017 HAS BEEN DOCUMENTED. (B)(6) 2018 - THE PATIENT WAS DIAGNOSED WITH A RECURRENT HERNIA UPON PHYSICAL EXAM. THE PATIENT DID NOT UNDERGO ADDITIONAL IMAGING OR SURGICAL INTERVENTION AS IT IS REPORTED THE SUBJECT REFUSED FURTHER TREATMENT. IT IS REPORTED THE SUBJECT PATIENT GAINED 31 LBS IN THE LAST 7 MONTHS. THE HERNIA RECURRENCE HAS BEEN ASSESSED AS POSSIBLY REL

  Patient problems: Abdominal Pain; Hernia

  MAUDE report 7378873 ↗