Novafil 8886 4410-03Recalls & reported problems
Covidien LP · Monofilament Polybutester · Class 2 · Implant
All models of Novafil (39)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Covidien Novafil suture is a nonabsorbable synthetic monofilament used to close incisions and wounds. Its 68 reports mostly describe the suture coming apart from the needle or breaking mid-procedure, so a replacement suture had to be used; no deaths and no injuries were reported. One open recall, started in December 2022, concerns a packaging seal breach in the breather pouch that could allow infection.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 68
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10884521099685), received between Dec 21, 2017 and Dec 25, 2025 — classified as 68 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (48 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Detachment of Device or Device Component48
- Break24
Patient problems
- No Clinical Signs, Symptoms or Conditions57
- Insufficient Information14
- No Consequences Or Impact To Patient4
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A COSMETIC SURGERY, TWO SUTURES DETACHED FROM THE NEEDLE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23892584 ↗MalfunctionDec 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A COSMETIC SURGERY, TWO SUTURES DETACHED FROM THE NEEDLE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23892576 ↗MalfunctionNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN INCISION PROCEDURE, DURING SUTURING OF THE INCISION, BOTH NEEDLE AND THREAD BROKE. A SUPPLEMENTAL SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23585607 ↗MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING INCISION CLOSURE, THE NEEDLE AND THREAD DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 23486979 ↗MalfunctionAug 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, ON SKIN CLOSURE, THE NEEDLE AND SUTURE BROKE WHILE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22859892 ↗MalfunctionJul 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE SUTURE WAS DISCONNECTED FROM THE NEEDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22608749 ↗MalfunctionJul 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD. TO RESOLVE THE ISSUE, RE-SUTURING WAS PERFORMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22590606 ↗MalfunctionJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN SCAR REPAIR, ON INCISION SUTURE, THE NEEDLE AND THREAD DETACHED. THE USER FIXED WITH STITCH REINFORCED STITCHING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22342898 ↗MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A SCAR REPAIR PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22236597 ↗MalfunctionJan 8, 2025Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN INCISION, THE THREAD BROKE WHEN SUTURING THE INCISION. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21102795 ↗MalfunctionDec 27, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21028434 ↗MalfunctionOct 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING AN OPEN EYE SURGERY, WHEN SUTURING VIA CONVENTIONAL STITCHING. BOTH NEEDLE AND THREAD WERE BROKEN. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20365307 ↗MalfunctionOct 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A SCAR REPAIR SURGERY, WHEN SUTURING, BOTH THE NEEDLE AND THREAD DETACHED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20365199 ↗MalfunctionApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN OPENING THE PACKAGE, IMMEDIATELY FOUND THAT THE NEEDLE AND THREAD WERE DETACHED WHILE IN RETAINER/HOLDER. IT WAS NOT USED. IT WAS NOTED THAT AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19199390 ↗MalfunctionApr 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE PACKAGE WAS OPENED, IT WAS IMMEDIATELY FOUND THAT THE NEEDLE AND THREAD WERE SEPARATED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19153527 ↗MalfunctionFeb 25, 2024Break; Break
ACCORDING TO THE REPORTER, DURING SKIN SUTURING, THE THREAD BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18775069 ↗MalfunctionFeb 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SKIN SUTURING, BOTH THE NEEDLE AND THREAD BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18773864 ↗MalfunctionFeb 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE TIME OF SUTURING, THE NEEDLE AND THREAD SEPARATED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18655846 ↗MalfunctionFeb 6, 2024Break; Break
ACCORDING TO THE REPORTER, THE NEEDLE TIP WAS BROKEN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18655734 ↗MalfunctionFeb 6, 2024Break; Break
ACCORDING TO THE REPORTER, DURING PROCEDURE, THE THREAD BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18652297 ↗MalfunctionJan 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THERE WAS A SEPARATION OF NEEDLE AND THREAD CONNECTION DURING SUTURING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18504830 ↗MalfunctionDec 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A HEMORRHOIDECTOMY, OPEN PROCEDURE, SKIN SUTURING, THE NEEDLE AND SUTURE DETACHED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18422822 ↗MalfunctionDec 20, 2023Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE THREAD BROKE WHILE SUTURING THE SKIN. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18367395 ↗MalfunctionDec 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE FOR HEMORRHOIDS, WHILE ON SKIN SUTURING PROCESS, THE NEEDLE AND THREAD SEPARATED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18340617 ↗MalfunctionDec 13, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN SUTURING THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18323449 ↗
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, ClassifiedTi-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
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices
- FAST-FIX 72202468Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 death6,626 reports
- FAST-FIX 72201491Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE863 reports
- FAST-FIX 72202469Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE561 reports
- FAST-FIX 72205676Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE439 reports
- Arthrex® AR-4501Arthrex, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE403 reports
- FAST-FIX 72205324Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE383 reports
- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- FAST-FIX 72201494Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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