Novafil 8886 4420-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521099869), received between Feb 15, 2023 and Feb 23, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionFeb 23, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SUTURE NEEDLE HAD BROKEN. THE NEEDLE CAME OFF THE THREAD.

  Patient problems: Insufficient Information

  MAUDE report 16428214 ↗
• MalfunctionFeb 23, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SUTURE NEEDLE HAD BROKEN. THE NEEDLE CAME OFF THE THREAD.

  Patient problems: Insufficient Information

  MAUDE report 16428182 ↗
• MalfunctionFeb 16, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SUTURE NEEDLE HAD BROKE. THE NEEDLE CAME OFF THE THREAD.

  Patient problems: Insufficient Information

  MAUDE report 16386662 ↗
• MalfunctionFeb 16, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHEN SKIN SUTURING WAS PERFORMED, THE SUTURE NEEDLE HAD BROKEN. THE NEEDLE CAME OFF THE THREAD. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16385384 ↗
• MalfunctionFeb 15, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHEN SKIN SUTURING PERFORMED, THE SUTURE NEEDLE HAD BROKE. THE NEEDLE CAME OFF THE THREAD. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16379929 ↗

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