CYTOSURG T8665CRecalls & reported problems
Riverpoint Medical, LLC · Suture · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810020084634), received between Dec 20, 2023 and Dec 20, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2023Break; Break
ACCORDING TO THE REPORTER, "PER SALES REPRESENTATIVE, 'DR. (B)(6) LET ME KNOW THAT HE HAD 3 SUTURES FROM THE BELOW BOX BREAK DURING A SURGERY AND THAT THEY MAY BE DEFECTIVE.'"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18363797 ↗MalfunctionDec 20, 2023Break; Break
ACCORDING TO THE REPORTER, "PER SALES REPRESENTATIVE, 'DR. WEISS LET ME KNOW THAT HE HAD 3 SUTURES FROM THE BELOW BOX BREAK DURING A SURGERY AND THAT THEY MAY BE DEFECTIVE.'"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18363758 ↗MalfunctionDec 20, 2023Break; Break
ACCORDING TO THE REPORTER, "PER SALES REPRESENTATIVE, 'DR. WEISS LET ME KNOW THAT HE HAD 3 SUTURES FROM THE BELOW BOX BREAK DURING A SURGERY AND THAT THEY MAY BE DEFECTIVE.'"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18363652 ↗
Other Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene devices
- 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
- CYTOSURG T8682CRiverpoint Medical, LLC · 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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