Novafil 8886 4401-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521118348), received between Mar 6, 2018 and Nov 5, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. Dec 2, 2022Class IIOpen, Classified

   Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

   Z-1175-2023 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN FLAP ATTACHMENT, WHILE SUTURING, THE NEEDLE DETACHED FROM THE THREAD OF THE SUTURE FOR ALL 5 DEVICE. NO DEVICE COMPONENT FELL INTO THE PATIENT CAVITY. EXTRA SUTURES WERE REQUIRED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610736 ↗
• MalfunctionNov 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN FLAP ATTACHMENT, WHILE SUTURING THE SUTURE THREAD DETACHED FROM NEEDLE FOR BOTH DEVICE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610501 ↗
• MalfunctionNov 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN FLAP ATTACHMENT, WHILE SUTURING, THE NEEDLE DETACHED FROM THE THREAD OF THE SUTURE FOR ALL 5 DEVICE. NO DEVICE COMPONENT FELL INTO THE PATIENT CAVITY. EXTRA SUTURES WERE REQUIRED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610467 ↗
• MalfunctionNov 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN FLAP ATTACHMENT, WHILE SUTURING, THE NEEDLE DETACHED FROM THE THREAD OF THE SUTURE FOR ALL 5 DEVICE. NO DEVICE COMPONENT FELL INTO THE PATIENT CAVITY. EXTRA SUTURES WERE REQUIRED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610466 ↗
• MalfunctionNov 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN FLAP ATTACHMENT, WHILE SUTURING, THE NEEDLE DETACHED FROM THE THREAD OF THE SUTURE FOR ALL 5 DEVICE. NO DEVICE COMPONENT FELL INTO THE PATIENT CAVITY. EXTRA SUTURES WERE REQUIRED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610419 ↗
• MalfunctionOct 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN FLAP ATTACHMENT, WHILE SUTURING, THE NEEDLE DETACHED FROM THE THREAD OF THE SUTURE ON ALL FIVE DEVICES. NO DEVICE COMPONENT FELL INTO THE PATIENT CAVITY. EXTRA SUTURES WERE REQUIRED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396876 ↗
• MalfunctionOct 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN FLAP ATTACHMENT, WHILE SUTURING, THE SUTURE THREAD DETACHED FROM NEEDLE FOR BOTH DEVICE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20396737 ↗
• MalfunctionJan 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE THREAD OF THE DEVICE DISLODGED FROM THE NEEDLE CONNECTION. SURGEON USED ANOTHER SUTURE DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167030 ↗
• MalfunctionMay 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN CAME OUT OF THE PACKET, THE NEEDLE DETACHED FROM THREAD. ADDITIONAL NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8652577 ↗
• MalfunctionMar 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLI10: ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN OCTOBER 2006 AND APRIL 2007, IN A PROSPECTIVE, RANDOMISED TRIAL OF 54 HANDS IN 47 PATIENTS INCISIONS WERE RANDOMISED TO BE CLOSED BY EITHER ABSORBABLE SUBCUTICULAR OR NON-ABSORBABLE INTERRUPTED SUTURES AFTER SINGLE PORTAL ENDOSCOPIC RELEASE OF THE CARPAL TUNNEL. TWENTY-EIGHT HANDS WERE AVAILABLE FOR FOLLOW UP FOR ABSORBABLE SUBCUTICULAR SUTURE GROUP COMPARED TO THE GROUP WHO RECEIVED NON-ABSORBABLE INTERRUPTED SUTURE. ONE PATIENT FROM EACH GROUP HAD INFLAMMATION OF THE WOUND DURING THE FIRST 14 DAYS AFTER THE OPERATION, BUT THE SYMPTOMS RESOLVED AND AT 3 MONTHS VISIT, THERE WERE NO OTHER COMPLICATIONS. PLI20: ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN OCTOBER 2006 AND APRIL 2007, IN A PROSPECTIVE, RANDOMISED TRIAL OF 54 HANDS IN 47 PATIENTS INCISIONS WERE RANDOMISED TO BE CLOSED BY EITHER ABSORBABLE SUBCUTICULAR OR NON-ABSORBABLE INTERRUPTED SUTURES AFTER SINGLE PORTAL ENDOSCOPIC RELEASE OF THE CARPAL TUNNEL. TWENTY-EIGHT HANDS WERE AVAILABLE FOR FOLLOW UP FOR ABSORBABLE SUBCUTICULAR SUTURE GROUP COMPARED TO THE GROUP WHO RECEIVED NON-ABSORBABLE INTERRUPTED SUTURE. ONE PATIENT FROM EACH GROUP HAD INFLAM

  Patient problems: Inflammation

  MAUDE report 8392507 ↗
• MalfunctionMar 23, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE FIRST STITCH, THE THREAD BROKE. PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7366688 ↗
• MalfunctionMar 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, UPON OPENING THE PACKAGE, THE DEVICE DID NOT HAVE ITS THREAD ATTACHED TO ITS NEEDLE. ANOTHER DEVICE WITH THE SAME CONFIGURATION OF THE NEEDLE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7318253 ↗

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