MONOTEX T8001CRecalls & reported problems
Riverpoint Medical, LLC · SUTURE · Class 2
- 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 00812444020540), received between May 15, 2026 and May 15, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
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.
MalfunctionMay 15, 2026Material Integrity Problem
ACCORDING TO THE REPORTER, "WE RECEIVED A COMPLAINT FROM OUR CUSTOMER REGARDING THE SUTURE BEING OFF THE NEEDLE ON TWO UNITS. WE RECEIVED ANOTHER COMPLAINT THIS WEEK FOR THE SAME THING, BUT A DIFFERENT LOT (LOT #25052102)".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25194219 ↗
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- 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.