NAMIC 70095007 (UDI H965700950070)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965700950070), received between Dec 19, 2016 and Jul 18, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Air Leak” (1 report).

1 other recall cover devices cleared under the same FDA submission (K873955); 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.

• MalfunctionJul 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), WHEN UTILIZING AN ANGIOGRAPHIC CONVENIENCE KIT, " AFTER THE LINES WERE CONNECTED WITH CONTRAST AND SALINE, THE CONTROL SYRINGE WAS CONNECTED TO THE MANIFOLD. THEN, AS AIR REMOVAL WAS ATTEMPTED, A FOREIGN SUBSTANCE WS FOUND INSIDE THE SYRINGE." THERE WERE NO PATIENT COMPLICATIONS NOR INJURY. THE USED SYRINGE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8802722 ↗
• MalfunctionDec 19, 2016Air Leak; Air Leak

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), WHILE UTILIZING A 10 ML ANGIOGRAPHIC SYRINGE CONNECTED TO A CONVENIENCE KIT, AIR WAS NOTED IN THE SYSTEM OF THE KIT COMPONENTS. THE MANIFOLD ASSEMBLY FROM THE CONVENIENCE KIT WAS RETURNED ALONG WITH THE SYRINGE. NO PATIENT INJURY RESULTED FROM THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6185433 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K873955. One submission often covers many models, so check the product and lot details in each record.

• Z-1712-2026 · Feb 27, 2026 · Open, Classified
  NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,T