Novafil 8886 4419-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521099760), received between Dec 7, 2021 and May 9, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE REMOVAL OF SKIN FROM THE NECK OF THE PATIENT, UPON SKIN CLOSURE, THE THREAD FELL OFF THE NEEDLE THAT WAS STILL IN THE NEEDLE HOLDER. THE THREAD FELL ON THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281867 ↗
• MalfunctionMar 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE FASCIAL SURGERY VIA OPEN PROCEDURE, WHILE SUTURING THE WOUND, BOTH NEEDLE AND THREAD BROKE. THE THREAD LOOSEN FROM THE NEEDLE. TO RESOLVE THE ISSUE, THE SURGEON OPENED ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654063 ↗
• MalfunctionFeb 9, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE SKIN, THE THREAD BROKE ON TWO OCCASIONS WITHOUT ANY HEAVY LOAD.

  Patient problems: Insufficient Information

  MAUDE report 13497284 ↗
• MalfunctionDec 7, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHILE SUTURING, THE NEEDLE BROKE. TO RESOLVE THE ISSUE, ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12954219 ↗
• MalfunctionDec 7, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NEEDLE OF THE DEVICE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12954151 ↗

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-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
• 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