NAMIC 64000935Recalls & reported problems
Navilyst Medical, Inc. · PROTECTION STATION · 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 H965640009350), received between Mar 28, 2016 and Mar 28, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K852140); they may or may not involve this specific model.
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
- Tear, Rip or Hole in Device Packaging1
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.
MalfunctionMar 28, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF THE CLOSED FLUID SYSTEM POUCH, BREACHING THE STERILITY. THE PRODUCT HAD NOT BEEN PROVIDED TO A HOSPITAL AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 5529865 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K852140. One submission often covers many models, so check the product and lot details in each record.
- Z-0764-2025 · Dec 16, 2024 · Open, ClassifiedMedline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,
- Z-1807-2024 · Mar 12, 2024 · Open, ClassifiedNamic FLUID DELIVERY SET, REF 91300040
- Z-1853-2017 · Jan 13, 2017 · TerminatedNAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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