Monosof N-2532Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521075993), received between Sep 19, 2017 and Apr 24, 2026 — classified as 1 injury, 7 malfunctions.

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

2 other recalls 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Break

  ACCORDING TO THE REPORTER, DURING A REPLANTATION OF THE AMPUTATED RIGHT MIDDLE FINGER WITH PLASTER SPLINT EXTERNAL FIXATION, DURING VASCULAR SUTURING, THE SUTURE BROKE WHILE KNOTTING. AS THE REMAINING SUTURE LENGTH WAS INSUFFICIENT, THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988485 ↗
• MalfunctionAug 4, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DEEP INFERIOR EPIGASTRIC PERFORATOR (DIEP) SURGERY, THE THREAD OF THE DEVICE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466958 ↗
• MalfunctionJun 22, 2021Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A VASCULAR ANASTOMOSIS, IT WAS FOUND THAT THE SUTURE WAS EASILY DEFORMED WHEN CLAMPED BY THE MICROSCOPIC DEVICE. WHEN THE SUTURE WAS KNOTTED, IT COULD NOT BE FORCED AND WAS EASY TO BREAK. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041028 ↗
• MalfunctionJul 21, 2019Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN DIEP FLAP PROCEDURE, THE DEVICE, NEEDLE WAS NOT SHARP AND THE THREAD BROKE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8810104 ↗
• MalfunctionMar 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LIVER TRANSPLANT VASCULAR ANASTOMOSIS PROCEDURE, THE SURGEON PERFORMED A CONTINUOUS SUTURING, AND UPON STITCHING THE DEVICE NEEDLE AND THREAD SEPARATED TO EACH OTHER. THEY THEN USED ANOTHER SUTURE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8441395 ↗
• MalfunctionJan 31, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN LIVER TRANSPLANTATION, THE SUTURES AND THE NEEDLES WERE FOUND DETACHED. THE SEPARATION OF THE SUTURES AND THE NEEDLES OCCURRED DURING THE SUTURING PROCESS, WHICH LED TO THE FAILURE OF THE SUTURE. THE SUTURE WAS REPLACED TO COMPLETE THE CASE. THE SURGERY TIME WAS EXTENDED BUT NOT EXCEEDING 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8292260 ↗
• InjuryJan 23, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, TWO HOURS INTO AN OPEN LIVER TRANSPLANTATION, NEEDLE SEPARATION OCCURRED AFTER THE PRODUCT PACKAGING WAS OPENED. THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE DUE TO THE REPORTED CONDITION. AN X-RAY WAS PERFORMED TO CONFIRM ALL PIECES WERE LOCATED. ANOTHER SUTURE HAD TO BE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 8272688 ↗
• MalfunctionSep 19, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY DURING SUTURING IN A LAPAROSCOPIC PROCEDURE, THE DEVICE NEEDLE POPPED OFF THE SUTURE. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT OUTCOME WAS ASKED BUT UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6876368 ↗

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-1174-2023 · Dec 2, 2022 · Open, Classified
  Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 10
• 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