Novafil 8886 4424-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521099951), received between Mar 25, 2026 and Mar 25, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K990952); 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. AN ADDITIONAL NEW SUTURE WAS USED BUT ALSO BROKE. ANOTHER SAME SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691422 ↗
• MalfunctionMar 25, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. AN ADDITIONAL NEW SUTURE WAS USED BUT ALSO BROKE. ANOTHER SAME SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691334 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990952. One submission often covers many models, so check the product and lot details in each record.

• Z-1175-2023 · Dec 2, 2022 · Open, Classified
  Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8
• Z-1181-2023 · Dec 2, 2022 · Open, Classified
  Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 8