TYRX™ NMRM6133 (UDI 00643169983540)Recalls & reported problems
Medtronic, Inc. · ENVELOPE NMRM6133 ABSORB LRG US MKT · Class 2 · Implant
All models of TYRX (11)
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 00643169983540), received between Apr 16, 2018 and Apr 16, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT INTRA-OPERATIVELY, PRIOR TO USE WHEN THE ANTIBACTERIAL ENVELOPE INTERNAL PACKAGING WAS OPENED IT WAS DISCOVERED THAT THERE WAS A FOREIGN MATERIAL ON THE PACKAGING. THE ENVELOPE WAS NOT UTILIZED AND THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 7434566 ↗
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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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