TIGR® Matrix Surgical Mesh NSTM2030Recalls & reported problems
Novus Scientific AB · 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
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07332999000024), received between Nov 30, 2015 and Nov 30, 2015 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K092224, K163005); 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Asthma1
- Scleroderma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 30, 2015Adverse Event Without Identified Device or Use Problem
DURING THE AUTUMN OF 2014, THE PATIENT REPORTED INCREASING IN FATIGUE, MUSCLE PAIN, LOCALIZED STIFFNESS AND THICKENING OF THE SKIN ON THE BODY AND PROXIMAL TO THE EXTREMITIES. FURTHERMORE, THE PATIENT REPORTED TINGLING SENSATIONS IN THE LEFT UPPER LIMB AND THE LEFT SIDE OF THE FACE. FINALLY, SHE HAD DYSPNEA AND LIGHT CHEST TIGHTNESS. DERMATOLOGISTS / RHEUMATOLOGISTS HAVE DIAGNOSED STEPWISE AND NOT GENERALIZED SCLERODERMA (MORPHEA). SINCE A PET-CT SCAN HAS SHOWN A REACTION IN THE ABDOMINAL WALL IN RELATION TO THE IMPLANTED MESH, ONE HAS SUSPECTED AN IMMUNOLOGICAL REACTION TO MESH MATERIAL. THE PATIENT HAS BEEN TREATED WITH IMMUNOSUPPRESSIVE THERAPY AND UVA LIGHT THERAPY WITH REASONABLE EFFECT ON THE SYMPTOMS. THE PATIENT HAS ALSO BEEN DIAGNOSED A SLIGHT BRONCHIAL ASTHMA.
Patient problems: Asthma; Scleroderma
MAUDE report 5253879 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K092224, K163005. One submission often covers many models, so check the product and lot details in each record.
- Z-2603-2016 · Jul 19, 2016 · TerminatedTIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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