AngioDynamics 06597004Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787065970040), received between Jan 2, 2018 and Mar 5, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (K051655); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Fracture

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A STD 5F M.I. KIT 45CM SS/SS ECHO. DURING A NEURO IR PROCEDURE, THE GUIDEWIRE FRAYED AND IT WAS THOUGHT THAT PART OF IT WAS RETAINED IN THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 24517790 ↗
• MalfunctionMay 7, 2025Difficult to Remove; Difficult to Remove

  AN END USER REPORTED AN ISSUE WITH A STD 5F M.I. KIT 45CM SS/SS ECHO. DURING A PROCEDURE, THE GUIDEWIRE TIP BECAME STUCK INSIDE THE PATIENT. A CUT DOWN WAS PERFORMED AND THE WIRE TIP WAS COMPLETELY REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21977285 ↗
• MalfunctionApr 8, 2020Fracture; Fracture

  FDA MEDWATCH REFERENCE MW5093078 WAS RECEIVED ON MARCH 26 2020. THE FOOD AND DRUG ADMINISTRATION REPORTED THAT A RISK MANAGER, FROM (B)(6) HOSPITAL, SUBMITTED A SUS VOLUNTARY EVENT REPORT FOR OUR 5F STANDARD MICRO-INTRODUCER KIT. THE REPORT STATES THAT A PIECE OF THE MICRO-INTRODUCER BROKE DURING AN INTERVENTIONAL RADIOLOGY PROCEDURE. IT WAS REPORTED BY THE END USER THAT THE PATIENT EXPERIENCED A SERIOUS INJURY. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9939861 ↗
• InjuryJan 2, 2018Knotted; Knotted

  AS REPORTED TO ANGIODYNAMICS ON DECEMBER 05, 2017: PER USER MEDWATCH (B)(4) RECEIVED: THE PATIENT WAS ADMITTED WITH DIAGNOSIS SVT FOR ABLATION SVT, EPS WITH 3D MAPPING. WHILE THE PHYSICIAN WAS OBTAINING VENOUS ACCESS TO THE PATIENT'S LEFT FEMORAL VEIN, THE MINISTICK WIRE INADVERTENTLY BECAME KNOTTED UP AND STUCK IN THE SUBCUTANEOUS TISSUE. THE POSITION OF THE WIRE WAS UNCHANGED AT THE END OF THE STUDY. THE PATIENT'S PARENTS WERE NOTIFIED. ANOTHER DOCTOR WAS CONSULTED; NO NEED TO REMOVE THE PIECE OF WIRE. THE PROCEDURE WAS COMPLETED; THE PATIENT WAS DISCHARGED THE NEXT DAY. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7156789 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051655. One submission often covers many models, so check the product and lot details in each record.

• Z-0418-2021 · Oct 14, 2020 · Terminated
  Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H7870
• Z-0772-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 0659703
• Z-0776-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 0659
• Z-0778-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or catheter into the vascular s
• Z-0777-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 0659
• Z-0773-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046
• Z-0775-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051
• Z-0774-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050
• Z-1405-2013 · Apr 30, 2013 · Terminated
  AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standar