CYTOSURG T8682CRecalls & reported problems
Riverpoint Medical, LLC · Suture · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810020084641), received between Sep 19, 2025 and Sep 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Dull, Blunt” (1 report).
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
Most reported problems
Device problems
- Dull, Blunt1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2025Dull, Blunt; Dull, Blunt
ACCORDING TO THE REPORTER, "OUR CUSTOMER EXPRESSED DIFFICULTY PASSING THROUGH THE TISSUE MORE THAN ONE TIME AND NEEDED TO OPEN ANOTHER SUTURE STATING THE NEEDLE WAS DULL. THERE ARE NO REMAINING SUTURES FORM THE COMPLAINT BOX/LOT AVAILABLE FOR RETURN AND THERE IS NO REPORT OF PATIENT HARM OR ADVERSE EVENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23102373 ↗
Other Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene devices
- CYTOSURG T8665CRiverpoint Medical, LLC · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene3 reports
- Cytoplast™ PTFE Suture CS0618PREMOsteogenics Biomedical Inc · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene2 reports
- MONOTEX T8695CRiverpoint Medical, LLC · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene2 reports
- Maxima 1127253Henry Schein, Inc. · SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE1 report
- Maxima 1127260Henry Schein, Inc. · SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE1 report
- Maxima 1127256Henry Schein, Inc. · SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE1 report
- MONOTEX T8001CRiverpoint Medical, LLC · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene1 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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