NAMIC 806010012Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H7498060100120), received between May 16, 2018 and Aug 7, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Air Leak” (2 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2018Leak/Splash; Leak/Splash

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), " IT WAS REPORTED THAT THERE WAS AIR LEAKING INTO THE MANIFOLD WHEN WITHDRAWING FLUID INTO THE SYRINGE. THERE WAS NO REPORTED PATIENT INJURY." THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7756338 ↗
• MalfunctionJul 10, 2018Leak/Splash; Leak/Splash

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), " IT WAS REPORTED THAT THERE WAS A MANIFOLD TODAY THAT KEPT ENTRAINING AIR. BOTH THE SCRUB NURSE AND THE CONSULTANT CHECKED THE MANIFOLD CONNECTIONS AND WERE UNABLE TO FIND WHERE IT WAS ENTRAINING FROM. THERE WAS NO REPORTED PATIENT INJURY". THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7673692 ↗
• MalfunctionJun 27, 2018Air Leak; Air Leak

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), " THE MANIFOLD WAS DRAWING IN AIR - THE HEALTH PROFESSIONAL FOUND A FAULTY MANIFOLD THIS MORNING. PRIMED USING EVERYTHING FROM BARD PACK BUT KEPT DRAWING IN AIR SOMEHOW WHEN ASPIRATING SYRINGE. AS A TEST SHE HAD ALL TAPS FLAT (CLOSED TO ALL PORTS) APART FROM THE INJECTOR SYRINGE, SHE THEN PUT HER FINGER ON THE LEFT HAND PORT AND ASPIRATED VIA THE SYRINGE ON RIGHT HAND PORT AND IT CONTINUED TO WITHDRAW AIR. THERE WAS NO REPORTED PATIENT INJURY." IT HAS BEEN INDICATED THAT THE USED DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7641009 ↗
• MalfunctionMay 16, 2018Air Leak; Air Leak

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN MALAYSIA, A HOSPITAL REPORTED THAT "AIR WAS BEING ENTRAINED INTO THE (BLOOD PRESSURE TRANSDUCER) MANIFOLD SYSTEM WITH NO OBVIOUS LOOSE CONNECTION FOUND. THERE WAS NO REPORTED PATIENT INJURY." THE USED MANIFOLD HAS BEEN RETURNED TO ANGIODYNAMICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7518355 ↗