AngioDynamics 06597052Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787065970520), received between Jun 5, 2019 and Oct 29, 2024 — classified as 4 malfunctions.

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

• MalfunctionOct 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A STF 4F M.I. KIT 45CM NT/T ECHO S. THE CUSTOMER REPORTED THEY HAD A PROBLEM WITH THE DEVICE. THE SHEATH HAD BEEN PLACED AND THE GUIDEWIRE INSERTED. WHEN REMOVING THE GUIDEWIRE AND PULLING THE SHEATH OUT OF THE PATIENT, THE SHEATH SHAFT DETACHED FORM THE "HUB" AND WAS RETAINED INSIDE THE PATIENT. THE RETAINED PORTION HAD TO BE RETRIEVED. THERE WAS NO HARM TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20557603 ↗
• MalfunctionOct 10, 2023Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A STF 4F M.I. KIT 45CM NT/T ECHO S. DURING A PROCEDURE, THE INTRODUCER BROKE INSIDE OF THE PATIENT. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17907100 ↗
• MalfunctionJun 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH THIS STF4F M.I. KIT. DURING A PROCEDURE, THE NITINOL TUNGSTEN 0.018" GUIDEWIRE SEPARATED AT THE TIP TRANSITION AND GOT STUCK IN THE PATIENTS FISTULA. THIS OCCURRED AFTER THE MICROPUNCTURE SHEATH WAS ADVANCED OVER THE WIRE. THE FISTULA WAS CLOTTED; THEREFORE, THE GUIDEWIRE DID NOT MIGRATE BUT THE PHYSICIAN HAD TO SNARE THE WIRE OUT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. 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 10148705 ↗
• MalfunctionJun 5, 2019Fracture; Fracture

  VENUS ACCESS ON A PATIENT USING 4F STIFF MICRO INTRODUCER KIT. WHILE THEY WERE PUTTING THE INTRODUCER ON THE WIRE, IT (THE INTRODUCER) APPEARED TO HAVE SHEARED OFF OF AT THE TIP. THE TREATING PHYSICIAN WAS UNABLE TO REMOVE THE TIP FROM THE PATIENT'S SUBCUTANEOUS TISSUE. IT WAS REPORTED THAT THE PATIENT SUFFERED NO SERIOUS HARM OR INJURY DUE TO THIS 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

  MAUDE report 8670488 ↗

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-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-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-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-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