AngioDynamics 06597051Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H787065970510), received between Jul 22, 2025 and Aug 4, 2025 — classified as 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionAug 4, 2025Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  ANGIODYNAMICS RECEIVED NOTIFICATION OF MEDWATCH (B)(4) REGARDING A STF 5F M.I. KIT 45CM NT/T ECHO B. IT WAS REPORTED THAT DURING RFV [RIGHT FEMORAL VEIN] TEMPORARY PACER PLACEMENT, MINI STICK WIRE KNOTTED AND TRAPPED, BROKE OFF INTO RFV. THE RN CONTACTED THE MD ON CALL TO COME AND PERFORM A SURGICAL CUTDOWN TO REMOVE THE WIRE. THE OR TEAM ARRIVED FOR CUTDOWN AND THE PATIENT UNDERWENT A VASCULAR CUTDOWN FOR THE KNOTTED WIRE STUCK IN THE GROIN UNDER LOCAL LIDO AND MODERATE SEDATION.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701068 ↗
• MalfunctionJul 22, 2025Entrapment of Device; Detachment of Device or Device Component

  CCL [CARDIAC CATHETERIZATION LAB] TEAM ARRIVED. DURING RFV [RIGHT FEMORAL VEIN] TEMPORARY PACER PLACEMENT, MINI STICK WIRE KNOTTED AND TRAPPED BROKE OFF INTO RFV. RN CONTACTED [REDACTED] MD ON CALL. PER STAFF, CONTACT VASCULAR. RN [REDACTED] CONTACTED MD TO COME AND PERFORM A SURGICAL CUTDOWN TO REMOVE WIRE. ALL MD'S ARE AWARE. OR TEAM ARRIVED FOR CUTDOWN, CASE DETAILS IN CHARTING. PATIENT UNDERWENT A VASCULAR CUTDOWN FOR KNOTTED WIRE STUCK IN GROIN UNDER LOCAL LIDO AND MODERATE SEDATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22564032 ↗

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: H7870659
• 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-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-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-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-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