NAMIC 70055003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965700550030), received between May 10, 2016 and Jun 30, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K842829); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 5761378 ↗
• MalfunctionMay 10, 2016Tear, 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 SMALL HOLE WAS FOUND IN THE TYVEK PORTION OF A STOPCOCK KIT 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 5644390 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K842829. One submission often covers many models, so check the product and lot details in each record.

• Z-2574-2021 · Aug 6, 2021 · Terminated
  NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile; (
• Z-2575-2021 · Aug 6, 2021 · Terminated
  NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (2) NAMIC STOPCOCK, 200 psi