NAMIC 90701482 (UDI H965907014820)Recalls & reported problems
Navilyst Medical, Inc. · PRESSURE MONITORING LINE 48" · Class 1
- 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 H965907014820), received between Aug 16, 2019 and Aug 16, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (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
- Crack1
- Fluid/Blood Leak1
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.
MalfunctionAug 16, 2019Crack; Fluid/Blood Leak
PATIENT'S A-LINE WAS NOT TRANSDUCING. THE NURSE USED PAPAVERINE, AS WELL AS FLUSHING AND REPOSITIONING WHICH DID NOT RESOLVE THE PROBLEM. WHILE INSTILLING THE PAPAVERINE INTO THE TUBING, A CRACK WAS DISCOVERED IN THE NAMIC PRESSURE MONITORING LINE TUBING AT THE CONNECTION POINT WITH THE PAPAVERINE SYRINGE AND A SMALL PUDDLE HAD FORMED ON THE SYRINGE PUMP. THE TUBING WAS CHANGED, AND THE LEAKING WAS RESOLVED. TWO DAYS LATER, A CRACK WAS FOUND IN A SECOND NAMIC PRESSURE MONITORING TUBING AT THE CONNECTION POINT WITH THE SYRINGE AND A PUDDLE FORMED ON THE SYRINGE PUMP. IN THIS CASE, A POOR TRACING WAS NOTED AND WAS RESOLVED WHEN THE TUBING WAS CHANGED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8900834 ↗
Other MONITOR, LINE ISOLATION devices
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- NAMIC 80641722Medline Industries, Inc. · MONITOR, LINE ISOLATION1 recall0 reports
- NAMIC 90701482Medline Industries, Inc. · MONITOR, LINE ISOLATION2 reports
- NAMIC 90701122Medline Industries, Inc. · MONITOR, LINE ISOLATION2 reports
- NAMIC 80641482Medline Industries, Inc. · MONITOR, LINE ISOLATION2 reports
- NAMIC 90701362Medline Industries, Inc. · MONITOR, LINE ISOLATION2 reports
- NAMIC 90701722Medline Industries, Inc. · MONITOR, LINE ISOLATION1 report
- NAMIC 80641242Navilyst Medical, Inc. · MONITOR, LINE ISOLATION1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.