Monosof SN-662Recalls & reported problems
Covidien LP · Monofilament Nylon · Class 2 · Implant
All models of Monosof (89)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521079663), received between Dec 19, 2017 and May 6, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (6 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.
Reports received per month
Most reported problems
Device problems
- Break6
- Detachment of Device or Device Component4
- Bent2
- Component Missing1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE SUTURES BROKE IN THE MIDDLE WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE EVENT WAS ASSOCIATED WITH A PATIENT, AND THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY AND NO CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25090393 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, TWO SUTURES BROKE IN THE MIDDLE WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE EVENT WAS ASSOCIATED WITH A PATIENT, AND THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY AND NO CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25090392 ↗MalfunctionNov 6, 2023Break; Break
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN SUTURING, THE SUTURE BROKE IN HALF. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18075367 ↗MalfunctionJan 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD WAS COMING OFF THE SUTURE.
Patient problems: Insufficient Information
MAUDE report 16206613 ↗MalfunctionJan 19, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD WAS COMING OFF THE SUTURE AND BROKE. THE INCIDENT OCCURRED FOR MORE THAN THREE TIMES.
Patient problems: Insufficient Information
MAUDE report 16206109 ↗MalfunctionJan 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE THREAD CAME OFF THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 16204130 ↗MalfunctionJan 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE THREAD CAME OFF THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 16203662 ↗MalfunctionApr 30, 2020Component Missing; Component Missing
ACCORDING TO THE REPORTER, THE SUTURE PACK WAS EMPTY. THERE WAS NO PATIENT INJURY
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10013440 ↗MalfunctionDec 21, 2017Bent; Break; Bent; Break
ACCORDING TO THE REPORTER, THE DEVICE NEEDLE WAS BREAKING AND BENDING. NO PATIENT INVOLVEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7139082 ↗MalfunctionDec 19, 2017Bent; Break; Bent; Break
ACCORDING TO THE REPORTER, THE DEVICE NEEDLE WAS BROKEN AND BENT. NO PATIENT INVOLVEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7132430 ↗
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, ClassifiedMonofilament 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, ClassifiedMonosof 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
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE devices
- ETHILON 697GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE223 reports
- ETHILON 698GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE119 reports
- ETHILON 1696GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE118 reports
- Monosof SN-3695Covidien LP · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls3 reports
- McKesson S661GXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls2 reports
- Surgilon 88861919-41Covidien LP · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls2 reports
- McKesson S931BXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls2 reports
- McKesson S697GXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls1 report
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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page