TIGR® Matrix Surgical Mesh NSTM1520Recalls & 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 07332999000239), received between Sep 24, 2024 and Sep 24, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Seroma1
- Wound Dehiscence1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
GLOBAL MEDICAL PARTNERS IS THE INITIAL IMPORTER OF THE TIGR MATRIX SURGICAL MESH (MANUFACTURED BY NOVUS SCIENTIFIC AB (SWEDEN). ON 01-AUG-2024, GLOBAL MEDICAL PARTNERS, LLC FIRST BECAME AWARE OF A MEDWATCH REPORT (MW5157343) SUBMITTED BY A PATIENT, WHO SUFFERED FROM COMPLICATIONS AFTER A BREAST LIFT SURGERY, WHERE THE TIGR MATRIX SURGICAL MESH WAS USED. THE PATIENT INDICATED THAT SHE HAD DEVELOPED A SEROMA IN BOTH BREASTS, AND THAT THE INCISION SEPARATED IN MULTIPLE AREAS, WITH PIECES OF MESH PROTRUDING OUT OF EACH OPEN AREA. PATIENT ALSO INDICATED THAT THIS HAS CAUSED A LENGTHY RECOVERY WITH EXTENDED FOLLOW UP CARE, AND THAT A SCAR REVISION SURGERY WOULD BE NECESSARY IN THE FUTURE. ON 06-AUG-2024, AFTER OBTAINING ADDITIONAL INFORMATION FROM THE SURGEON, DR. (B)(6) ((B)(6) PLASTIC SURGERY), GLOBAL MEDICAL PARTNERS, LLC INFORMED THE MANUFACTURER - NOVUS SCIENTIFIC AB (UPPSALLA, SWEDEN) OF THIS MEDWATCH REPORT, PROVIDED THE ADDITIONAL DETAILS FROM THE SURGEON, AND REQUESTED THE MANUFACTURER TO INFORM GLOBAL MEDICAL PARTNERS IF THE DECISION WOULD BE MADE TO SUBMIT A MEDICAL DEVICE REPORT TO FDA. DR. (B)(6) PROVIDED THE FOLLOWING TIMELINE OF EVENTS: (B)(6) 2023 - SURGERY. (B)(6) 2023 -
Patient problems: Seroma; Wound Dehiscence
MAUDE report 20292709 ↗
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
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- 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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