Phasix 1201010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741095320), received between Mar 1, 2023 and Jun 25, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A HIATAL HERNIA REPAIR WITH FUNDOPLICATION ON (B)(6) 2024 THE PATIENT WAS IMPLANTED WITH PHASIX ST MESH. AS REPORTED THE SURGEON ¿THINKS IT¿S POSSIBLE THE PATIENT MAY HAVE AN EROSION DUE TO THE FACT THAT THE PATIENT HAD A STROKE 4-WEEKS POST-OP.¿ AS REPORTED THE SUTURES DIDN¿T HOLD, AND HE BELIEVES ¿PART OF THE SUTURE AND MESH MAY HAVE ERODED INTO THE ESOPHAGUS.¿ PER THE SURGEON, NO ADDITIONAL SURGERY IS GOING TO BE PERFORMED AT THIS TIME. THE PATIENT IS STABLE AND WILL BE DISCHARGED.

  Patient problems: Erosion

  MAUDE report 19609128 ↗
• InjuryFeb 22, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT WAS DIAGNOSED WITH LARGE HIATAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF PHASIX ST MESH ON (B)(6) 2023. DURING THE PROCEDURE, THE DIAPHRAGMATIC ABUTMENTS WERE CLOSED AND THEN THE MESH WAS PLACED TO REINFORCE THE AREA OF FRAGILITY RESULTING FROM THE VOLUMINOUS HERNIA. THE PATIENT VISITED THE HOSPITAL AT VARIOUS TIMES WITHOUT MAJOR COMPLAINTS AND UNDERWENT UPPER GASTROINTESTINAL ENDOSCOPY IN (B)(6) 2023 WITH NO FINDING OF UNEXPECTED CHANGES FOR THE POSTOPERATIVE PERIOD OF HIATAL HERNIA REPAIR. IN (B)(6) 2023, PATIENT VISITED HOSPITAL WITH SYMPTOMS OF SEVERE DYSPHAGIA, PROGRESSING TO COMPLETE DYSPHAGIA FOR SOLIDS AND PARTIAL DYSPHAGIA FOR LIQUIDS ASSOCIATED WITH WEIGHT LOSS. PATIENT UNDERWENT UPPER GASTROINTESTINAL ENDOSCOPY IN (B)(6) 2024 AND SUSPECTED A FOREIGN BODY INSIDE THE ESOPHAGUS. ON (B)(6) 2024, PATIENT UNDERWENT A NEW ENDOSCOPY TO REMOVE PART OF THE FOREIGN BODY AND NASOENTERIC TUBE WAS PASSED FOR ADEQUATE FEEDING. AFTER THE PROCEDURE, PART OF THE MATERIAL WAS SENT FOR PATHOLOGICAL ANALYSIS. IN THE VISUAL ANALYSIS, IT WAS CONFIRMED THAT THE MATERIAL WAS THE PHASIX ST MESH PREVIOUSLY PLACED DURING THE HIATAL HERNIA REPAIR. THE PAT

  Patient problems: Dysphagia/ Odynophagia; Erosion

  MAUDE report 18760319 ↗
• InjuryMar 1, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL PHASIX ST AND VENTRALIGHT ST ON (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); Fibrosis; Hematoma; Insufficient Information; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 16459171 ↗