AngioDynamics 06597202Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787065972020), received between Apr 13, 2016 and Apr 13, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2016Break; Fracture; Material Separation; Break; Fracture; Material Separation

  PER (B)(4) RECEIVED (B)(6) 2016, A (B)(6), MALE PATIENT PRESENTED FOR A LEFT COMMON ILIAC ARTERY ANGIOPLASTY AND STENT PLACEMENT. DURING THE PROCEDURE, THE TREATING PHYSICIAN EXPERIENCED DIFFICULTY ACCESSING THE LEFT FEMORAL ARTERY DUE TO HEAVY SCAR TISSUE AND PATCH MATERIAL. THE TREATING PHYSICIAN WAS ABLE TO PLACE THE STENTS, HOWEVER ONCE THEY WERE PLACED, THE MICRO-INTRODUCER GUIDEWIRE UNRAVELED INSIDE OF THE PATIENT, CAUSING THE TIP OF THE GUIDEWIRE TO FRACTURE OFF INSIDE OF THE PATIENT. FLUOROSCOPY WAS USED TO DETERMINE THE LOCATION OF THE REMAINING PIECE INSIDE OF THE PATIENT. IT WAS DETERMINED NOT TO REMOVE THE PIECE AS IS WAS LODGED WITHIN THE PATIENT'S TISSUE AND NOT WITHIN THE VESSEL. IT WAS REPORTED THE PATIENT SUFFERED NO HARM OR INJURY DUE TO THE EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 5573768 ↗

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-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-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-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-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-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-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