ReNew 3251Recalls & reported problems
Microline Surgical, Inc. · Lapclinch Grasper Tip, Reusable · Class 2
All models of ReNew (45)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811099011682), received between Jun 26, 2023 and Jun 26, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Jul 13, 2017Terminated
The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.
Z-0507-2018 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Fragmentation1
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.
MalfunctionJun 26, 2023Material Fragmentation; Material Fragmentation
ITEM NO. 3251 BROKE DURING SURGERY, THE END ABOVE THE HEAT SHRINK BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17197588 ↗
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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 · 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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