PLASMAFIT NT414RRecalls & reported problems
Aesculap AG · CUP INSERT.INSTR.W/THREAD M8X1 STR SHORT · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964027475), received between Nov 10, 2020 and Nov 10, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Disconnect” (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.
Most reported problems
Device problems
- Failure to Disconnect1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2020Failure to Disconnect; Failure to Disconnect
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NT414R - CUP INSERT.INSTR.W/THREAD M8X1 STR. ACCORDING TO THE COMPLAINT DESCRIPTION, THE INSTRUMENT COULD NOT BE TURNED OFF AFTER IMPLANTATION OF THE PLASMAFIT CUP. BOTH IMPACTORS WERE USED IN THE SAME SURGERY. THE SURGERY WAS CONTINUED WITH A THIRD-PARTY PRODUCT. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENT: NV254T - PLASMAFIT PLUS 3 CUP SIZE 54MM H - BATCH: 52621612.
Patient problems: Insufficient Information
MAUDE report 10817182 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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