Sofradim Production
FDA adverse event reports naming Sofradim Production as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: SOFRADIM PRODUCTION.
- Total reports
- 4,887
- Deaths
- 8
- Injuries
- 4,621
- Malfunctions
- 205
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Mesh, Surgical, PolymericFTL2,464
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorOTN1,948
- Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally PlacedOTP338
- Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally PlacedOTO91
- Mesh, SurgicalFTM30
- Mesh, Surgical, Non-Absorbable, Large Abdominal Wall DefectsOXJ5
- Product code ------3
- Laparoscope, General & Plastic SurgeryGCJ3
- System, Dialysate Delivery, Single PassFIL2
- Electrode, Ph, StomachFFT1
Recent recalls
- 2018-04-26TerminatedOther
Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material.
There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdominis Muscle Release (TAR) procedures.
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