Novafil CPB-738GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521163577), received between Sep 17, 2019 and Oct 27, 2022 — classified as 1 injury, 1 malfunction.

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.

• InjuryOct 27, 2022Break; Break

  ACCORDING TO THE REPORTER, POSTOPERATIVE TO OPEN LAPARATOMY, THE THREAD BROKE. THE PATIENT WAS BROUGHT BACK TO THE THEATER, ANOTHER DEVICE WAS USED AND WAS VENTILATED AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information; Ventilator Dependent

  MAUDE report 15683676 ↗
• MalfunctionSep 17, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING CLOSING OF SHEATH IN A SKIN CLOSURE PROCEDURE, WHILE DOING AN INTERRUPTED SUTURING, THE THREAD BROKE AT THE END OF CLOSING OF SHEATH. THREAD REPEATED BREAKING WITHOUT MUCH TENSION. ANOTHER SUTURE WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9076314 ↗

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