PDO, Violet, 1, 30cm, Taper Point, 5/8 circle, 26mm, uni-directional VLP-2053Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · PDO, Violet, 1, 30cm, Taper Point, 5/8 circle, 26mm, uni-directional · Class 2 · Implant
Data updated Oct 18, 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 00848782004805), received between Sep 7, 2021 and Sep 7, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 7, 2021Break
THE SURGEON SAYS THE NEEDLE BROKE OFF FROM THE THREAD UPON ENTRY INTO ABDOMEN THROUGH THE 8MM ROBOTIC TROCAR DURING THE ROBOTIC VENTRAL HERNIA REPAIR. THE NEEDLE THEN FLEW ACROSS THE ABDOMEN AND THEY COULDN¿T FIND IT. THEY EVENTUALLY FOUND IT VIA AN X-RAY.
Patient problems: Foreign Body In Patient
MAUDE report 12435987 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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