Monosof SN-5697Recalls & reported problems
Covidien LP · Monofilament Nylon · Class 2 · Implant
All models of Monosof (89)
Data updated Oct 16, 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.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521079137), received between Jan 31, 2024 and Jan 31, 2024 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (10 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 16, 2026.
Reports received per month
Recalls naming this device
- Dec 2, 2022Open, 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
- Break10
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2024Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, AFTER OPENING THE PACKAGE, THE THREAD BROKE ON TEN SUTURES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619722 ↗MalfunctionJan 31, 2024Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, AFTER OPENING THE PACKAGE, THE THREAD BROKE ON TEN SUTURES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619713 ↗MalfunctionJan 31, 2024Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, AFTER OPENING THE PACKAGE, THE THREAD BROKE ON TEN SUTURES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619710 ↗MalfunctionJan 31, 2024Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, AFTER OPENING THE PACKAGE, THE THREAD BROKE ON TEN SUTURES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619334 ↗MalfunctionJan 31, 2024Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, AFTER OPENING THE PACKAGE, THE THREAD BROKE ON TEN SUTURES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619326 ↗MalfunctionJan 31, 2024Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, AFTER OPENING THE PACKAGE, THE THREAD BROKE ON TEN SUTURES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619304 ↗MalfunctionJan 31, 2024Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, AFTER OPENING THE PACKAGE, THE THREAD BROKE ON TEN SUTURES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619285 ↗MalfunctionJan 31, 2024Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, AFTER OPENING THE PACKAGE, THE THREAD BROKE ON TEN SUTURES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619271 ↗MalfunctionJan 31, 2024Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, AFTER OPENING THE PACKAGE, THE THREAD BROKE ON TEN SUTURES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619239 ↗MalfunctionJan 31, 2024Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, AFTER OPENING THE PACKAGE, THE THREAD BROKE ON TEN SUTURES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619171 ↗
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 S931BXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls2 reports
- McKesson S661GXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls2 reports
- Surgilon 88861919-41Covidien LP · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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