NAMIC 90703122 (UDI H965907031220)Recalls & reported problems
Navilyst Medical, Inc. · ARTERIAL EXTENSION SET 12" · Class 2
All models of NAMIC (41)
Data updated Oct 16, 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 H965907031220), received between Dec 7, 2018 and Dec 7, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Misassembled” (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
- Component Misassembled1
Patient problems
- Not Applicable1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 7, 2018Component Misassembled; Component Misassembled
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), BLUE NON-VENTED PORT PROTECTOR CAP CONNECTED TO STOPCOCK END PORT FITTING SHOULD HAVE BEEN A VENTED WHITE PORT PROTECTOR CAP. THE NON-VENTED CAP POSSIBLY COMPROMISES A STERILE PATHWAY FOR THIS DEVICE DURING THE STERILIZATION PROCESS. THIS ONE UNIT WAS FOUND DURING 100% INCOMING INSPECTION AT THE DISTRIBUTOR AND HAD NOT BEEN DISTRIBUTED TO A HOSPITAL.
Patient problems: Not Applicable
MAUDE report 8141221 ↗
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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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