Monosof N-2730-KRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10884521076266), received between Mar 2, 2020 and Sep 22, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860227 ↗
• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860225 ↗
• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860224 ↗
• MalfunctionSep 14, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50764177 ↗
• MalfunctionMay 7, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A CORNEA REPAIR, THE THREAD BROKE IN THE MIDDLE AFTER TWO OR THREE PASSAGES INTO THE CORNEA. THE THREAD WAS REMOVED, AND THE SURGEON STARTED AGAIN WITH A NEW SUTURE. THE PROCEDURE WAS LONGER DUE TO SUTURE REPAIR, BUT IT DID NOT EXCEED 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978862 ↗
• MalfunctionApr 29, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPHTHALMOLOGICAL PROCEDURE, THE SUTURE THREAD 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 21927602 ↗
• MalfunctionApr 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SUTURE STRAND DETACHED FROM THE NEEDLE, RESULTING IN AN EXTENDED SURGICAL TIME BY HALF AN HOUR. THE HEALTHCARE PROFESSIONAL HAD TO USE FIVE UNITS INSTEAD OF ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878265 ↗
• MalfunctionApr 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SUTURE STRAND DETACHED FROM THE NEEDLE, RESULTING IN AN EXTENDED SURGICAL TIME BY HALF AN HOUR. THE HEALTHCARE PROFESSIONAL HAD TO USE FIVE UNITS INSTEAD OF ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878252 ↗
• MalfunctionApr 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SUTURE STRAND DETACHED FROM THE NEEDLE, RESULTING IN AN EXTENDED SURGICAL TIME BY HALF AN HOUR. THE HEALTHCARE PROFESSIONAL HAD TO USE FIVE UNITS INSTEAD OF ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878212 ↗
• MalfunctionApr 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SUTURE STRAND DETACHED FROM THE NEEDLE, RESULTING IN AN EXTENDED SURGICAL TIME BY HALF AN HOUR. THE HEALTHCARE PROFESSIONAL HAD TO USE FIVE UNITS INSTEAD OF ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878164 ↗
• MalfunctionApr 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SUTURE STRAND DETACHED FROM THE NEEDLE, RESULTING IN AN EXTENDED SURGICAL TIME BY HALF AN HOUR. THE HEALTHCARE PROFESSIONAL HAD TO USE FIVE UNITS INSTEAD OF ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878114 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, WHEN IT WAS TIME TO SEW, THE THREAD BROKE BECAUSE IT WAS TOO THIN. SEVERAL ATTEMPTS WERE MADE WITH OTHER THREADS FROM DIFFERENT BATCH, ALL OF WHICH ALSO BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679027 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, WHEN IT WAS TIME TO SEW, THE THREAD BROKE BECAUSE IT WAS TOO THIN. SEVERAL ATTEMPTS WERE MADE WITH OTHER THREADS FROM DIFFERENT BATCH, ALL OF WHICH ALSO BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678714 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, WHEN IT WAS TIME TO SEW, THE THREAD BROKE BECAUSE IT WAS TOO THIN. SEVERAL ATTEMPTS WERE MADE WITH OTHER THREADS FROM DIFFERENT BATCH, ALL OF WHICH ALSO BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678628 ↗
• MalfunctionMar 20, 2025Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, IT WAS NOTED THAT THE SUTURE APPEARED DIFFERENT. THERE WAS SUTURE DISCOLORATION. THE SUTURE WAS GRAY INSTEAD OF BLACK. THE THICKNESS ALSO RESEMBLED OF A DIFFERENT SUTURE AND THE TENSILE STRENGTH WAS SIGNIFICANTLY LOWER. THE SUTURE BROKE EASILY IN THE MIDDLE WHEN A KNOT WAS MADE AND PULLED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED FOR 5 MINUTES DUE TO THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649807 ↗
• MalfunctionFeb 21, 2025Product Quality Problem; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Product Quality Problem; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING AN OPHTHALMOLOGY PROCEDURE, THE SUTURE WAS DIFFICULT TO REMOVE FROM THE RETAINER/PACKAGING. A CHANGE IN THE SUTURE'S COLOR TO A BRIGHTER SHADE WAS ALSO OBSERVED. THE THREAD WAS NOTED TO BE MORE BRITTLE AND FRAGILE, BREAKING EASILY AT THE CONNECTION WHEN KNOTS WERE TIED. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434872 ↗
• MalfunctionFeb 13, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A CATARACT SURGERY, WHILE SUTURING, THE THREAD BROKE SPECIFICALLY IN THE MIDDLE. ANOTHER SUTURE FROM OTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED NOT MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378658 ↗
• MalfunctionJan 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, WHEN IT WAS TIME TO SEW, THE THREAD BROKE BECAUSE IT WAS TOO THIN. SEVERAL ATTEMPTS WERE MADE WITH OTHER THREADS FROM DIFFERENT BATCH, ALL OF WHICH ALSO BROKE. 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 21193095 ↗
• MalfunctionJan 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, WHEN IT WAS TIME TO SEW, THE THREAD BROKE BECAUSE IT WAS TOO THIN. SEVERAL ATTEMPTS WERE MADE WITH OTHER THREADS FROM DIFFERENT BATCH, ALL OF WHICH ALSO BROKE. 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 21191247 ↗
• MalfunctionJan 16, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT THE SUTURES BROKE, WERE TOO THIN AND BECAME LOOSE DURING SUTURING. AFTER TESTING SEVERAL THREADS, FROM THE SAME BOX, FROM THE SAME BATCH; OTHERS WERE OPENED THAT WERE OF BETTER QUALITY. THE PRODUCT WAS REPLACED BY ANOTHER PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 21168723 ↗
• MalfunctionJan 16, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT THE SUTURES BROKE, WERE TOO THIN AND BECAME LOOSE DURING SUTURING. AFTER TESTING SEVERAL THREADS, FROM THE SAME BOX, FROM THE SAME BATCH; OTHERS WERE OPENED THAT WERE OF BETTER QUALITY. THE PRODUCT WAS REPLACED BY ANOTHER MEDTRONIC PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168302 ↗
• MalfunctionDec 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPTHALMIC SURGERY, THE NEEDLE DETACHED FROM THE THREAD OF 2 SUTURES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10950811 ↗
• MalfunctionDec 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPTHALMIC SURGERY, THE NEEDLE DETACHED FROM THE THREAD OF 2 SUTURES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10950756 ↗
• MalfunctionMay 21, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN EYE PROCEDURE, THE DEVICE THREAD BROKE EASILY. 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 10079995 ↗
• MalfunctionMar 2, 2020Break; Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE THE DEVICE BROKE.

  Patient problems: No Information

  MAUDE report 9775240 ↗

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
• 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