Monosof SN-3697Recalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Covidien Monosof SN-3697 is a nonabsorbable nylon suture for closing tissue during surgery. The 32 adverse event reports mostly describe the thread snapping in the middle during procedures, sometimes with many sutures from the same batch breaking at once, and the thread or loop detaching; in each report a new suture was used to finish the operation. No deaths or injuries are mentioned. One open recall, started in December 2022, concerns a breach in the sterile pouch packaging that may 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
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10884521078048), received between Dec 4, 2018 and Jan 9, 2026 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Break” (26 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.
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-1174-2023 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break26
- Detachment of Device or Device Component6
Patient problems
- Insufficient Information14
- No Clinical Signs, Symptoms or Conditions14
- No Patient Involvement2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, TWELVE SUTURES HAD A BREAKAGE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 24019607 ↗MalfunctionJan 6, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE LOOP BROKE. THE ISSUE WAS RESOLVED BY CHANGING TO A NEW PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23973981 ↗MalfunctionDec 25, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD OF (B)(4) SUTURES BROKE IN THE MIDDLE, WHILE OTHER (B)(4) SUTURES FROM A DIFFERENT BATCH HAD THE SAME ISSUE. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 23892250 ↗MalfunctionDec 25, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD OF 15 SUTURES BROKE IN THE MIDDLE, WHILE OTHER 9 SUTURES FROM DIFFERENT BATCH HAD THE SAME ISSUE. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 23892249 ↗MalfunctionDec 25, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD OF 15 SUTURES BROKE IN THE MIDDLE, WHILE OTHER 9 SUTURES FROM DIFFERENT BATCH HAD THE SAME ISSUE. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 23892248 ↗MalfunctionDec 25, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD OF 15 SUTURES BROKE IN THE MIDDLE, WHILE OTHER 9 SUTURES FROM DIFFERENT BATCH HAD THE SAME ISSUE. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 23892246 ↗MalfunctionDec 25, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD OF 15 SUTURES BROKE IN THE MIDDLE, WHILE OTHER 9 SUTURES FROM DIFFERENT BATCH HAD THE SAME ISSUE. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 23892245 ↗MalfunctionDec 25, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD OF 15 SUTURES BROKE IN THE MIDDLE, WHILE OTHER 9 SUTURES FROM DIFFERENT BATCH HAD THE SAME ISSUE. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 23892244 ↗MalfunctionDec 25, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD OF 15 SUTURES BROKE IN THE MIDDLE, WHILE OTHER 9 SUTURES FROM DIFFERENT BATCH HAD THE SAME ISSUE. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 23892243 ↗MalfunctionDec 25, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD OF 15 SUTURES BROKE IN THE MIDDLE, WHILE OTHER 9 SUTURES FROM DIFFERENT BATCH HAD THE SAME ISSUE. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 23892242 ↗MalfunctionDec 25, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD OF 15 SUTURES BROKE IN THE MIDDLE, WHILE OTHER 9 SUTURES FROM DIFFERENT BATCH HAD THE SAME ISSUE. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 23892239 ↗MalfunctionDec 25, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD OF 15 SUTURES BROKE IN THE MIDDLE, WHILE OTHER 9 SUTURES FROM DIFFERENT BATCH HAD THE SAME ISSUE. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 23892236 ↗MalfunctionDec 25, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD OF 15 SUTURES BROKE IN THE MIDDLE, WHILE OTHER 9 SUTURES FROM DIFFERENT BATCH HAD THE SAME ISSUE. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 23892234 ↗MalfunctionJul 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, DURING THE SUTURING OF LACERATION, THE SUTURE BROKE OFF OF THE NEEDLE AFTER 2 STITCHES WERE PLACED. A SECOND SUTURE FROM ANOTHER LOT WAS OPENED, BUT THE SUTURE BROKE AWAY FROM THE NEEDLE AFTER 1 STITCH WAS PLACED SUCCESSFULLY. ANOTHER PACKAGE WAS OPENED FROM THE SAME LOT AND THE PROCEDURE WAS FINISHED WITHOUT ANY FURTHER INCIDENT.
Patient problems: Insufficient Information
MAUDE report 22621825 ↗MalfunctionJul 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, DURING THE SUTURING OF LACERATION, THE SUTURE BROKE OFF OF THE NEEDLE AFTER 2 STITCHES WERE PLACED. A SECOND SUTURE FROM ANOTHER LOT WAS OPENED, BUT THE SUTURE BROKE AWAY FROM THE NEEDLE AFTER 1 STITCH WAS PLACED SUCCESSFULLY. ANOTHER PACKAGE WAS OPENED FROM THE SAME LOT AND THE PROCEDURE WAS FINISHED WITHOUT ANY FURTHER INCIDENT.
Patient problems: Insufficient Information
MAUDE report 22614813 ↗MalfunctionApr 21, 2025Break; Break
IT WAS REPORTED THAT THE 24 SUTURES BROKE WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION. THE SAME PRODUCT WAS USED TO RESOLVE THE ISSUE. NUMBER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21872708 ↗MalfunctionApr 21, 2025Break; Break
IT WAS REPORTED THAT THE 24 SUTURES BROKE WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION. THE SAME PRODUCT WAS USED TO RESOLVE THE ISSUE. NUMBER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21872666 ↗MalfunctionApr 20, 2025Break; Break
IT WAS REPORTED THAT THE THIRTEEN SUTURES BROKE WHILE SUTURING. THE DEVICE WAS REPLACED WITH PRODUCT FROM ANOTHER LOT 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 21870306 ↗MalfunctionApr 20, 2025Break; Break
IT WAS REPORTED THAT THE THIRTEEN SUTURES BROKE WHILE SUTURING. THE DEVICE WAS REPLACED WITH PRODUCT FROM ANOTHER LOT 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 21870303 ↗MalfunctionMar 26, 2025Break; Break
IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS A BROKEN THREAD FOR THE 2 SUTURES. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21701544 ↗MalfunctionMar 26, 2025Break; Break
IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS A BROKEN THREAD FOR THE 2 SUTURES. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21701508 ↗MalfunctionApr 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN EYEBROW LACERATION PROCEDURE, THE SUTURE STRING OF TWO PIECES OF SUTURES FROM THE SAME BOX SNAPPED OFF THE NEEDLE IN THE MIDDLE OF THE PROCEDURE. A NEW SUTURE FROM A BRAND NEW BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19020534 ↗MalfunctionMar 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, MULTIPLE SUTURES (1 BOX) BROKE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18862013 ↗MalfunctionSep 23, 2021Break; Break
ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC PROCEDURE, WHILE PERFORMING THE CLOSING STITCH, THE NEEDLE BROKE. ANOTHER DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12523848 ↗MalfunctionSep 23, 2021Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE CLOSING THE INCISION, THE NEEDLE BROKE. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12523829 ↗
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
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 · 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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