CRURASOFT 0116003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741030840), received between Nov 8, 2020 and Nov 2, 2023 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 2, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE: "HIATAL HERNIA REPAIR WITH TENSION-FREE MESH OR CRURAL SUTURES ALONE IN ANTIREFLUX SURGERY". THIS ARTICLE REPORTS THE FINDING BASED ON A 13 YEAR FOLLOW-UP OF A CLINICAL TRIAL DESIGNED TO ASSESS THE LONG-TERM OUTCOMES OF USING A MESH FOR HIATAL HERNIA REPAIR IN PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE (GERD). THE CLINICAL TRIAL INITIALLY CONSISTED OF (B)(4) PATIENTS UNDERWENT ANTI REFLUX SURGERY FOR TREATMENT OF (GERD) AT A SINGLE CENTER FROM (B)(6), 2006 TO (B)(6), 2010. THE LAPAROSCOPIC REPAIR INCLUDED COMPLETE DISSECTION, MOBILIZATION OF THE HERNIA SAC AND THE MEDIASTINAL ESOPHAGUS. THE PATIENTS WERE RANDOMLY ALLOCATED TO EITHER THE SUTURE GROUP ((B)(4) PATIENTS) OR THE MESH GROUP ((B)(4) PATIENTS). ALL PATIENT¿S ALLOCATED TO THE MESH GROUP WERE IMPLANTED WITH A BARD/BD CRURASOFT MESH WHICH WAS SECURED WITH AT LEAST 3 SUTURES AND 10-15 NON-BARD/BD FIXATION TACKS. DURING FOLLOW-UP, 3 PATIENTS UNDERWENT REOPERATION IN THE MESH GROUP, AND 4 PATIENTS IN THE SUTURE GROUP, ALL DUE TO RECURRENT GERD. NONE OF THE INCLUDED PATIENTS REQUIRED RE-OPERATION DUE TO MESH-INDUCED COMPLICATIONS. OF THE PATIENTS WHO PARTICIPATED IN THE ONGOING STUDY, A TOTAL OF (B)(4) PAT

  Patient problems: Dysphagia/ Odynophagia; Hernia

  MAUDE report 18054282 ↗
• InjuryNov 8, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL CRURASOFT PATCH ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST CRURASOFT PATCH. 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 ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 10806699 ↗