AngioDynamics 06597014Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H787065970140), received between Aug 1, 2017 and May 12, 2020 — 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.

• MalfunctionMay 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  A DIRECTOR OF RISK MANAGEMENT REPORTED THAT AN IR PHYSICIAN ASSISTANT ATTEMPTED AN ULTRASOUND GUIDED PARACENTESIS, ACCESSING THE RIGHT UPPER QUADRANT, WITH A STD 5F M.I. KIT. WHILE ATTEMPTING TO GAIN ACCESS INTO THE PERITONEAL SPACE, A SMALL PORTION OF THE 018 GUIDEWIRE DISLODGED INTO THE PATIENT'S ABDOMEN. THE DISLODGED PORTION WAS NOT REMOVED AS IT WAS LODGED IN TISSUE AND THE GUIDEWIRE WAS NOT RETAINED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10048575 ↗
• InjuryAug 1, 2017Fracture; Fracture

  AS REPORTED TO ANGIODYNAMICS ON JULY 06, 2017 VIA USER MEDWATCH (B)(4): PATIENT TO CARDIAC CATH LAB FOR CARDIAC ELECTROPHYSIOLOGIC STUDY/CATHETER ABLATION ON (B)(6) 2017. MICRO-PUNCTURE WIRE BROKE AND LEFT A TINY PIECE IN THE LEFT GROIN SUBCUTANEOUS TISSUE AREA WHILE TRYING TO ENTER THE LEFT FEMORAL VEIN IN THE BEGINNING OF THE CASE. PEDS ECHO DONE ON DAY OF PROCEDURE; NO EVIDENCE OF CLOT OR THROMBUS FORMATION IN THE LEFT ATRIAL APPENDAGE. ON THE DAY AFTER THE PROCEDURE, VENOUS DOPPLER REPORT - NO EVIDENCE OF LEFT LOWER EXTREMITY ACUTE DEEP VENOUS THROMBOSIS. XRAY OF PELVIS DONE (B)(6) 2017 - SUGGESTION OF VERY THIN FOREIGN BODY ALONG THE MEDIAL ASPECT OF THE FEMORAL HEAD LIKELY REPRESENTING SMALL RETAINED WIRE. PHYSICIAN DETERMINED NOT TO REMOVE THE FRAGMENT. PATIENT DISCHARGED HOME (B)(6) 2017. 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 6756713 ↗

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-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-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-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-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-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-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-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-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