NAMIC 91400400Recalls & reported problems
Navilyst Medical, Inc. · Guidewire Introducer · Class 2
All models of NAMIC (41)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965914004000), received between Nov 2, 2018 and Nov 2, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (2 reports).
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
- Unsealed Device Packaging2
Patient problems
- Not Applicable2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 2, 2018Unsealed Device Packaging; Unsealed Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A COMPROMISED POUCH SEAL WAS FOUND ON A GUIDEWIRE INTRODUCER POUCH, THEREBY BREACHING STERILITY. THE POUCH HAD NOT BEEN PROVIDED TO A HOSPITAL AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 8032170 ↗MalfunctionNov 2, 2018Unsealed Device Packaging; Unsealed Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A COMPROMISED POUCH SEAL WAS FOUND ON A GUIDEWIRE INTRODUCER POUCH, THEREBY BREACHING STERILITY. THE POUCH HAD NOT BEEN PROVIDED TO A HOSPITAL AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 8032169 ↗
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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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