Monosof CN-830-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521075238), received between Aug 4, 2019 and Feb 2, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 reports).

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

1 other recall cover devices cleared under the same FDA submission (K900531); 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-1174-2023 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT DURING AN OPEN GASTRECTOMY PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE, RESULTING IN AN EXTENDED SURGICAL TIME OF 10 MINUTES. ANOTHER BATCH OF SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240469 ↗
• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN GASTRECTOMY PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE, RESULTING IN AN EXTENDED SURGICAL TIME OF 10 MINUTES. ANOTHER BATCH OF SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716248 ↗
• MalfunctionSep 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROTOMY PROCEDURE, THE 30 SUTURE THREADS WERE EASILY DETACHED FROM THE NEEDLE AND IT SEEMED THAT THE NEEDLE WAS NOT SUITABLE CONNECTED AROUND THE THREAD. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551137 ↗
• MalfunctionSep 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROTOMY PROCEDURE, THE SUTURE THREAD IS EASILY DETACHED FROM THE NEEDLE AND IT SEEMS THAT THE NEEDLE IS NOT SUITABLE CONNECTED AROUND THE SUTURE THREAD. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551132 ↗
• MalfunctionSep 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROTOMY PROCEDURE, THE SUTURE THREAD IS EASILY DETACHED FROM THE NEEDLE AND IT SEEMS THAT THE NEEDLE IS NOT SUITABLE CONNECTED AROUND THE SUTURE THREAD. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551121 ↗
• MalfunctionOct 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BOWEL SURGERY, HALFWAY THROUGH THE PROCEDURE, THE THREAD BROKE OFF FROM THE NEEDLE. THE SURGEON MANAGED TO FINISHED OFF TYING THE SUTURE WITH THE NEEDLE HOLDER WITHOUT THE NEEDLE ATTACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9176240 ↗
• MalfunctionSep 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD BROKE FROM THE NEEDLE.

  Patient problems: No Information

  MAUDE report 9130716 ↗
• MalfunctionSep 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BOWEL SURGERY, HALFWAY THROUGH THE PROCEDURE, THE THREAD BROKE OFF FROM THE NEEDLE. THE SURGEON MANAGED TO FINISHED OFF TYING THE SUTURE WITH THE NEEDLE HOLDER WITHOUT THE NEEDLE ATTACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 9126949 ↗
• MalfunctionAug 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, HALFWAY THROUGH THE SURGERY, THE THREAD BROKE FROM THE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8858492 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K900531. One submission often covers many models, so check the product and lot details in each record.

• Z-1173-2023 · Dec 2, 2022 · Open, Classified
  Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX