NAMIC 70030021Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H965700300210), received between Apr 12, 2016 and Mar 8, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K910764); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2017Tear, 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 DISPOSABLE TRANSDUCER PRODUCT 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 6388130 ↗
• MalfunctionMay 9, 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 THE DEVICE 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 5640920 ↗
• MalfunctionApr 12, 2016Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED BY (B)(4), HOLE IN THE PRODUCT POUCH WAS OBSERVED, WHICH BREACHED THE STERILITY. THE UNUSED DEVICE HAD NOT BEEN PROVIDED TO A HOSPITAL, AND WAS RETURNED TO (B)(4) FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 5570604 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K910764. One submission often covers many models, so check the product and lot details in each record.

• Z-1429-2025 · Feb 12, 2025 · Open, Classified
  namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160