NAMIC 70035009Recalls & reported problems

Navilyst Medical, Inc. · NAMIC 400psi Three-Way Stopcock with Rotating Adaptor · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI H965700350090), received between Jun 30, 2016 and Nov 7, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Tear, Rip or Hole in Device Packaging5

Patient problems

Not Applicable5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 7, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), IN THE DISTRIBUTOR'S WAREHOUSE A HOLE/TEAR WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK 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 9289626 ↗
MalfunctionAug 4, 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 A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 5847556 ↗
MalfunctionJun 30, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
AS REPORTED BY ANGIODYNAMIC'S DISTRIBUTOR IN (B)(4), IN THE DISTRIBUTOR'S WAREHOUSE A SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 5761377 ↗
MalfunctionJun 30, 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 A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 5761371 ↗
MalfunctionJun 30, 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 A STOPCOCK POUCH, BREACHING THE STERILITY. THE DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO ANGIODYNAMICS FOR EVALUATION.
Patient problems: Not Applicable
MAUDE report 5761370 ↗

Device details

UDI-DI	`H965700350090`
Brand	NAMIC
Model	70035009
Company	Navilyst Medical, Inc.
Product code	DTL · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 7, 2019

Device type (GMDN): Stopcock

A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.

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All Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass devices →

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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