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Biodesign G31455Recalls & reported problems

Cook Biotech Incorporated · Biodesign Hiatal Hernia Graft · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002314559), received between Oct 11, 2022 and Oct 11, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. Nov 22, 2024Open, Classified

    Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

    Z-0833-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Patient Device Interaction Problem1

Patient problems

  • Hernia1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 11, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

    A LAWYER CONTACTED COOK MEDICAL TO INFORM THEM OF A POTENTIAL PRODUCT LIABILITY CLAIM. PATIENT: (B)(6), LOT #: LB1143478, CATALOG #: G31455. (B)(6) 2022: COOK LEGAL INDICATED NO ADDITIONAL DETAILS RECEIVED. (B)(6) 2022: COOK LEGAL INDICATED STILL NO ADDITIONAL DETAILS RECEIVED. UPDATE: PATIENT MEDICAL RECORDS RECEIVED ON (B)(6) 2022. ON (B)(6) 2019, THE PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF HIATAL HERNIA WITH MESH; 2. UPPER ENDOSCOPY; AND 3. WEDGE RESECTION OF THE GASTRIC FUNDUS. PER THE OPERATIVE NOTE, THE PATIENT HAD SEVERE ESOPHAGITIS. LARGE AMOUNT OF RETAINED FOOD DEBRIS WITHIN THE STOMACH. MUCOSAL CHANGES WERE NOT VISIBLE DUE TO THE SHEER AMOUNT OF FOOD WITHIN THE STOMACH. ENTIRE STOMACH WAS INTRATHORACIC. VISIBLE WAS WHAT APPEARED TO BE A DEVITALIZED GASTRIC BODY ALONG THE LEFT CRUS AND ANTERIORLY THE STOMACH GOING UP INTO THE CHEST CAVITY APPEARED TO BE VIABLE. THE HIATAL DEFECT WAS QUITE LARGE. THE OMENTUM GOING UP INTO THE CHEST CAVITY ALSO APPEARED TO BE VIABLE. A VERY THICK AND INFLAMED HIATAL HERNIA SAC WAS COMPLETELY EXCISED AND BROUGHT BACK INTO THE ABDOMINAL CAVITY. CAREFUL INSPECTION OF THE STOMACH REVEALED THAT A GOOD PORTION OF THE GREATER CURVE OF THE STOMACH

    Patient problems: Hernia

    MAUDE report 15576326 ↗

Other Mesh, surgical, collagen, diaphragmatic hernia devices

All Mesh, surgical, collagen, diaphragmatic hernia devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.