SurgiMesh Tintra R-1415Recalls & reported problems
Bg Medical, LLC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00850011929032), received between Mar 5, 2026 and Mar 5, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Adhesive Too Strong” (1 report).
1 FDA recall record name this device's identifier.
1 other recall cover devices cleared under the same FDA submission (K072974); they may or may not involve this specific model.
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 18, 2026.
Reports received per month
Recalls naming this device
- Aug 12, 2022Class IICompleted
Potential presence of residual adhesive material on the mesh surface.
Z-1984-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adhesive Too Strong1
Patient problems
- Abdominal Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 5, 2026Adhesive Too Strong
ON 05-FEB-2026, CHAMBERLAIN TECHNOLOGIES BECAME AWARE OF A COMPLAINT INVOLVING A PREVIOUSLY IMPLANTED SURGIMESH XB DEVICE. THE DEVICE HAD BEEN IMPLANTED ON (B)(6) 2022. DURING A SUBSEQUENT SURGICAL PROCEDURE, THE SURGEON OBSERVED TISSUE ADHESION INVOLVING THE SILICONE-COATED SURFACE OF THE MESH. A PORTION OF THE MESH WAS SURGICALLY EXCISED. THE REMAINING PORTION OF THE DEVICE REMAINED IMPLANTED. NO PATIENT IMPACT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT HAS BEEN INITIATED. NO ADDITIONAL CLINICAL DETAILS HAVE BEEN PROVIDED TO DATE. INVESTIGATION REMAINS ONGOING.
Patient problems: Abdominal Pain
MAUDE report 24527651 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K072974. One submission often covers many models, so check the product and lot details in each record.
- Z-1985-2025 · Aug 12, 2022 · CompletedSURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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