Symbotex SYM3420EFRecalls & reported problems
Sofradim Production · Composite Mesh,Monofilament Polyester with Absorbable Collagen Film, Pre-Placed Sutures and Marking · Class 2 · Implant
All models of Symbotex (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521190559), received between May 9, 2022 and May 9, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Split, Cut or Torn1
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.
InjuryMay 9, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, FIVE YEARS AFTER THE LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH INCISIONAL HERNIA, THE PATIENT HAD AN INCISIONAL HERNIA AGAIN. RE-OPERATION WAS PERFORMED AND DURING THE SURGERY, IT WAS FOUND THAT, THE MESH HAD TEAR IN THE MIDDLE. A NEW MESH WAS PLACED ON THE TOP OF THE EXISTING ONE.
Patient problems: Hernia
MAUDE report 14341320 ↗
Other Mesh, surgical, polymeric devices
- PROCEED PVPMJohnson & Johnson International Inc. · Mesh, surgical, polymeric1,233 reports
- PROCEED PCDN1Johnson & Johnson International Inc. · Mesh, surgical, polymeric744 reports
- PROCEED PCDG1Johnson & Johnson International Inc. · Mesh, surgical, polymeric1 recall1 death637 reports
- PROCEED PVPSJohnson & Johnson International Inc. · Mesh, surgical, polymeric622 reports
- ProGrip LPG1510Sofradim Production · Mesh, surgical, polymeric2 deaths616 reports
- VENTRALEX 0010302Davol Inc. · Mesh, surgical, polymeric4 deaths531 reports
- BARD 0112680Davol Inc. · Mesh, surgical, polymeric1 death494 reports
- ProGrip TEM1509GSofradim Production · Mesh, surgical, polymeric3 deaths471 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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