OviTex 1SRecalls & reported problems across all models

We found 12 models of OviTex 1S by Aroa Biosurgery Limited in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2019 and Jul 27, 2026 — classified as 1 death, 42 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported OviTex 1S problems

OviTex 1S models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• OviTex® 1S F10246-2020P

  Mesh, Surgical, Polymeric
  1 death9 reports
• OviTex® 1S F10246-1012P

  Mesh, Surgical, Polymeric
  7 reports
• OviTex® 1S F10246-0610P

  Mesh, Surgical, Polymeric
  5 reports
• OviTex® 1S F10246-2530P

  Mesh, Surgical, Polymeric
  5 reports
• OviTex® 1S F10246-1620P

  Mesh, Surgical, Polymeric
  4 reports
• OviTex® 1S F10256-2020G

  Mesh, Surgical
  4 reports
• OviTex® 1S F10246-1822P

  Mesh, Surgical, Polymeric
  2 reports
• OviTex® 1S F10256-0610G

  Mesh, Surgical
  2 reports
• OviTex® 1S F10256-1012G

  Mesh, Surgical
  2 reports
• OviTex® 1S F10246-1020P

  Mesh, Surgical, Polymeric
  1 report
• OviTex® 1S F10256-1020G

  Mesh, Surgical
  1 report
• OviTex® 1S F10246-2540P

  Mesh, Surgical, Polymeric
  1 report

Recent OviTex 1S adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  A patient underwent paraesophageal hernia repair with OviTex 1S Resorbable on (b)(6) 2026. The patient reported ongoing difficulty advancing beyond a full liquid diet and on 11May26 reported weight loss but overall dysphagia improvement. On (b)(6) 2026 the patient reported worsening dysphagia with associated PO intolerance. The patient was admitted to the hospital on (b)(6) 2026 with diagnostic and therapeutic upper endoscopy on (b)(6) 2026 where a retained food bolus was identified in the distal esophagus with mild narrowing of the distal esophagus. A balloon dilation was performed after bolus removal and the patient discharged on (b)(6) 2026. The patient reported in (b)(6) 2026 ongoing improvement in symptoms and appropriate advancement of diet.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 50018969 ↗
• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT PARAESOPHAGEAL HERNIA REPAIR WITH OVITEX 1S RESORBABLE ON (B)(6) 2026. ON (B)(6) 2026 THE PATIENT REPORTED WORSENING DYSPHAGIA WITH ASSOCIATED PO INTOLERANCE. UPPER GI IMAGING WAS CONDUCTED ON (B)(6) 2026 WHICH DEMONSTRATED DELAYED ESOPHAGEAL EMPTYING AND NARROWING AT THE GE JUNCTION. THE PATIENT UNDERWENT EGD WITH BALLOON DILATION ON (B)(6) 2026 AND (B)(6) 2026 WITH NO ADDITIONAL INTERVENTIONS NOTED.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 25854210 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT A PATIENT WAS EXPERIENCING POTENTIAL MESH EROSION FROM A HIATAL HERNIA REPAIR. A REVISION PROCEDURE WAS CONDUCTED ON (B)(6) 2025. UPON ENTERING ABDOMEN VIA ROBOTIC PORTS, THE ORIGINAL DEVICE WAS FOUND AND REMOVED FROM SUPERIOR ASPECT OF STOMACH. IT WAS REPORTED THAT THE PERMANENT SUTURE HAD ERODED INTO SUPERIOR ASPECT OF FUNDOPLICATION. THIS WAS "REMOVED EASILY", STOMACH IRRIGATED WITH SALINE AND REPAIRED WITH RESORBABLE SUTURE. THE RECURRENT HIATAL HERNIA WAS THEN REPAIRED WITH SUTURES AND PLEDGETS.

  Patient problems: Erosion

  MAUDE report 24048331 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 11DEC2025 THAT A PATIENT WAS EXPERIENCING POTENTIAL MESH EROSION FROM A HIATAL HERNIA REPAIR. A REVISION PROCEDURE WAS CONDUCTED ON (B)(6) 2025. UPON ENTERING ABDOMEN VIA ROBOTIC PORTS, THE ORIGINAL DEVICE WAS FOUND AND REMOVED FROM SUPERIOR ASPECT OF STOMACH. IT WAS REPORTED THAT THE PERMANENT SUTURE HAD ERODED INTO SUPERIOR ASPECT OF FUNDOPLICATION. THIS WAS "REMOVED EASILY", STOMACH IRRIGATED WITH SALINE AND REPAIRED WITH RESORBABLE SUTURE. THE RECURRENT HIATAL HERNIA WAS THEN REPAIRED WITH SUTURES AND PLEDGETS.

  Patient problems: Erosion

  MAUDE report 24008981 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2024. THE PRIMARY REPAIR INCLUDED INCARCERATED BOWEL WHICH WAS REDUCED AND PRIMARY CLOSURE OBTAINED. THE PATIENT PRESENTED WITH A BULGE IN THE SUPRAUMBILICAL AREA IN (B)(6) 2025 WITH SUSPECTED HERNIA RECURRENCE. THE HERNIA WAS REDUCED AND REPAIRED ON (B)(6) 2025 VIA A ROBOTIC TAPP HERNIA REPAIR PROCEDURE.

  Patient problems: Hernia

  MAUDE report 23954720 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2024. THE PRIMARY REPAIR INCLUDED INCARCERATED BOWEL WHICH WAS REDUCED AND PRIMARY CLOSURE OBTAINED. THE PATIENT PRESENTED WITH A BULGE IN THE SUPRAUMBILICAL AREA IN (B)(6) 2025 WITH SUSPECTED HERNIA RECURRENCE. THE HERNIA WAS REDUCED AND REPAIRED ON (B)(6) 2025 VIA A ROBOTIC TAPP HERNIA REPAIR PROCEDURE.

  Patient problems: Hernia

  MAUDE report 23921942 ↗
• InjuryNov 10, 2025Migration; Migration

  A PATIENT UNDERWENT A DUAL ANASTOMOSIS CASE ON (B)(6) 2024, DURING WHICH ANASTOMOSES WERE PERFORMED ON THE UPPER AND LOWER COLON. AFTER THIS, A COMPLEX ABDOMINAL WALL CLOSURE WAS CONDUCTED. THE LOWER ANASTOMOSIS LEAKED AND THE PATIENT WAS READMITTED ON (B)(6) 2024. A CT IDENTIFIED ABSCESS WAS DRAINED WITH A SECOND DRAINAGE ON (B)(6) 2024. A FISTULA FORMED FROM THIS LOWER ANASTOMOSIS. INTESTINAL FAILURE TREATMENT COMMENCED ALONG WITH TOTAL PARENTERAL NUTRITION AND SURGICAL SCLEROSIS OF THE FISTULA UNTIL WELL ENOUGH FOR REPAIR OF LOWER ANASTOMOSIS FISTULA WHICH WAS SCHEDULED FOR ON (B)(6) 2025. A SKIN FISTULA PRESENTED INCLUDING THE PRESENCE OF POLYPROPYLENE SUTURE. A REOPERATION WAS CONDUCTED TO REMOVE A PORTION OF SUTURE MATERIAL WITH THE ABDOMINAL WALL REPAIR NOTED TO BE INTACT.

  Patient problems: Fistula

  MAUDE report 23511899 ↗
• InjuryOct 31, 2025Migration; Migration

  A PATIENT UNDERWENT A DUAL ANASTOMOSIS CASE ON (B)(6) 2024, DURING WHICH ANASTOMOSES WERE PERFORMED ON THE UPPER AND LOWER COLON. AFTER THIS, A COMPLEX ABDOMINAL WALL CLOSURE WAS CONDUCTED. THE LOWER ANASTOMOSIS LEAKED AND THE PATIENT WAS RE-ADMITTED ON (B)(6) 2024. A CT IDENTIFIED ABSCESS WAS DRAINED WITH A SECOND DRAINAGE ON (B)(6) 2024. A FISTULA FORMED FROM THIS LOWER ANASTOMOSIS. INTESTINAL FAILURE TREATMENT COMMENCED ALONG WITH TOTAL PARENTERAL NUTRITION AND SURGICAL SCLEROSIS OF THE FISTULA UNTIL WELL ENOUGH FOR REPAIR OF LOWER ANASTOMOSIS FISTULA WHICH WAS SCHEDULED FOR (B)(6) 2025. A SKIN FISTULA PRESENTED INCLUDING THE PRESENCE OF POLYPROPYLENE SUTURE. A REOPERATION WAS CONDUCTED TO REMOVE A PORTION OF SUTURE MATERIAL WITH THE ABDOMINAL WALL REPAIR NOTED TO BE INTACT.

  Patient problems: Fistula

  MAUDE report 23437828 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HIATAL HERNIA REPAIR WITH OVITEX 1SP AND THE LINX REFLUX MANAGEMENT SYSTEM ON (B)(6) 2025. THE PATIENT PRESENTED WITH DYSPHAGIA AND RETURNED FOR ENDOSCOPY ON (B)(6) 2025 WHERE POTENTIAL ENTRY INTO THE ESOPHAGUS WAS NOTED. THE SURGEON NOTED THAT THEY PLAN TO PERFORM AN ADDITIONAL ENDOSCOPY TO ADDRESS THE ISSUE.

  Patient problems: Dysphagia/ Odynophagia; Erosion

  MAUDE report 23432855 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HIATAL HERNIA REPAIR WITH OVITEX 1SP AND THE LINX REFLUX MANAGEMENT SYSTEM ON (B)(6) 2025. THE PATIENT PRESENTED WITH DYSPHAGIA AND RETURNED IN (B)(6) 2025 FOR ENDOSCOPY ON (B)(6) 2025 WHERE POTENTIAL ENTRY INTO THE ESOPHAGUS WAS NOTED. THE SURGEON NOTED THAT THEY PLAN TO PERFORM AN ADDITIONAL ENDOSCOPY TO ADDRESS THE ISSUE.

  Patient problems: Dysphagia/ Odynophagia; Erosion

  MAUDE report 23323099 ↗
• InjuryAug 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A HERNIA REPAIR (IPOM) WITH OVITEX 1S PERMANENT IN APPROXIMATELY (B)(6) 2025. THE CASE WAS PLANNED TO BE LAPAROSCOPIC BUT WAS CONVERTED TO OPEN. ON (B)(6) 2025, THE PATIENT RETURNED TO THE EMERGENCY ROOM AND WAS TAKEN IN FOR SURGERY. DURING THIS SURGERY, THE SURGICAL SITE APPEARED INFECTED, AND ADHESIONS WERE PRESENT. THE DEVICE WAS REMOVED AND A SMALL BOWEL RESECTION PERFORMED.

  Patient problems: Adhesion(s); Bacterial Infection

  MAUDE report 22881649 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A HERNIA REPAIR (IPOM) WITH OVITEX 1S PERMANENT IN APPROXIMATELY (B)(6) 2025. THE CASE WAS PLANNED TO BE LAPAROSCOPIC BUT WAS CONVERTED TO OPEN. ON (B)(6) 2025, THE PATIENT RETURNED TO THE EMERGENCY ROOM AND WAS TAKEN IN FOR SURGERY. DURING THIS SURGERY, THE SURGICAL SITE APPEARED INFECTED AND ADHESIONS WERE PRESENT. THE DEVICE WAS REMOVED AND A SMALL BOWEL RESECTION PERFORMED.

  Patient problems: Adhesion(s); Bacterial Infection

  MAUDE report 22877982 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HIATAL HERNIA SURGERY REPAIR REINFORCED WITH OVITEX 1S. APPROXIMATELY 6 MONTHS LATER, THE PATIENT UNDERWENT REOPERATION FOR SUSPECTED POTENTIAL ESOPHAGEAL EROSION. UPON REOPERATION THE SURGEON NOTED A SMALL PIECE OF POLYPROPYLENE SUTURE IN APPOSITION TO THE ESOPHAGUS. THE SUTURE WAS REMOVED WITHOUT INCIDENT AND THE PATIENT HAD NO FURTHER COMPLICATIONS. THE DEVICE WAS REPORTED TO HAVE OTHERWISE BEEN INTEGRATED AND REMODELED.

  Patient problems: Erosion

  MAUDE report 22322602 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A POST-OPERATIVE INFECTION AND BOWEL OBSTRUCTION. THE LATTER LED TO BOWEL OBSTRUCTIVE SYMPTOMS AND RE-OPERATION WHERE ADHESIONS WERE NOTED. THE DEVICE WAS REMOVED AFTER ADHESIONS WERE FREED. THERE WAS NO REPORTED PERMANENT DAMAGE.

  Patient problems: Adhesion(s); Bacterial Infection; Obstruction/Occlusion

  MAUDE report 19968958 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A POST-OPERATIVE INFECTION AND BOWEL OBSTRUCTION. THE LATTER LED TO BOWEL OBSTRUCTIVE SYMPTOMS AND RE-OPERATION WHERE ADHESIONS WERE NOTED. THE DEVICE WAS REMOVED AFTER ADHESIONS WERE FREED. THERE WAS NO REPORTED PERMANENT DAMAGE.

  Patient problems: Adhesion(s); Bacterial Infection; Obstruction/Occlusion

  MAUDE report 19951531 ↗