AngioDynamics 06597015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H787065970150), received between May 2, 2019 and Jul 11, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

• MalfunctionJul 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN PERFORMED A FISTULOGRAM WITH A STD 4F M.I. KIT 45CM NT/T ECHO B. AT THE END OF THE PROCEDURE, THE POST PURSE STRING NYLON SUTURE WAS PLACED IN AND, UPON TYING, THE INTRODUCER TO THE MICRO PUNCTURE BROKE IN HALF. THE PHYSICIAN WAS ABLE TO RETRIEVE ALL PIECES VIA A CUT DOWN AND THE MICRO PUNCTURE WAS SENT OFF FOR PATHOLOGY EVALUATION. DESPITE MULTIPLE GOOD FAITH EFFORTS, NO FURTHER DETAILS HAVE BEEN OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721134 ↗
• InjuryMay 2, 2019Fracture; Fracture

  PER RECEIVED USER MEDWATCH 0504240000-2019-8006: PT UNDERGOING CEREBRAL ANGIOGRAM THE SITE WAS INJECTED WITH LIDOCAINE 1 % OVERLYING THE RIGHT COMMON FEMORAL ARTERY THE GROIN AND ARTERIAL ACCESS WAS GAINED USING A MICROPUNCTURE TECHNIQUE, WITH THE ACCESS WIRE IN PLACE THE MD WENT TO REMOVE THE MICROPUNCTURE SHEATH THE HUB DISCONNECTED FROM THE MAIN BODY OF THE SHEATH - WHEN THE MD PULLED ON THE MAIN BODY OF THE SHEATH, APPROXIMATELY ONE HALF OF IT CAME OFF. APPROX. 2 1/2 CM OF THE TIP WAS MISSING AND STILL ON THE WIRE, ATTEMPTS TO DISSECT WITH A HEMOSTAT DOWN THE WIRE TO IDENTIFY AND REMOVE - UNSUCCESSFUL ATTEMPT. THE LEFT COMMON FEMORAL ARTERY WAS ACCESSED WITH ULTRASOUND GUIDANCE, A 6F 11 CM SHEATH WAS PLACED AND FLUSHED, THROUGH THIS A SNARE WAS USED TO CAPTURE THE DISTAL END OF THE ACCESS WIRE AND WITHDRAW OUT THE LEFT FEMORAL ARTERY SHEATH - A 5CM SHEATH WAS PLACED OVER THE WIRE INTO THE RIGHT COMMON FEMORAL ARTERY - A 70 CM KUMPE WAS PASSED ANTEGRADE DOWN THE ACCESS WIRE AND THE TIP OF THE WAS PUSHED OUT THE LEFT SIDE OF THE GROIN - THERE WAS NOT HARM TO THE PATIENT ALL WAS RETRIEVED. IT WAS INDICATED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8575001 ↗

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-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-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-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-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-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-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