NAMIC 91051602Recalls & reported problems
Navilyst Medical, Inc. · High Pressure Contrast Injection Line · Class 2
Data updated Oct 13, 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 H749910516020), received between Aug 8, 2019 and Aug 8, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Improper Flow or Infusion” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Improper Flow or Infusion1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2019Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), END USER HOSPITAL WAS UTILIZING A 60" FLEXCIL CONTRAST INJECTION LINE (WITH F-M) FITTINGS ALONG WITH AN EDWARD'S EXTENSION TUBE WHICH WAS CONNECTED TO A NAMIC STOPCOCK. "AS PREPARATION, THE FIRST AIR INSIDE INJECTOR WAS REMOVED AND THE TUBING CONNECTIONS WERE SECURELY TIGHTENED. PRIOR PROCEDURE, CONTRAST MEDIA WAS FLASHED INTO A 10ML SYRINGE OF THE OPERATOR SIDE. THEN ANGIOGRAPHY PROCEDURE BEGAN BY AN INJECTOR (5ML INJECTED, 2ML/SEC). IMMEDIATELY AIR WAS OBSERVED IN THE CATHETER ON THE IMAGE. THEREFORE, THE OPERATOR STOPPED INJECTING THE CONTRAST MEDIA IMMEDIATELY AND STOPPED THE ANGIOGRAPHY PROCEDURE." NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE USED DEVICES WERE DISCARDED AT THE HOSPITAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8875673 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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