AngioDynamics 45754Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H965457540), received between May 31, 2018 and May 7, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

15 other recalls cover devices cleared under the same FDA submission (K132713); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2025Fracture; Fracture

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75". ON (B)(6) 2025 A PATIENT UNDERWENT LEFT GREATER SAPHENOUS VEIN VARITHENA PROCEDURE IN THE OFFICE WITH THE MINI STICK DEVICE. ON (B)(6) 2025 THE PATIENT WENT TO THE ER AND AN XRAY OF THEIR LEFT LEG REVEALED A PORTION OF THE RETAINED WIRE WITHIN THE SAPHENOUS VEIN. IT HAS YET TO BE REMOVED. THE DOCTOR BELIEVES IT WAS A DEFECTIVE WIRE OR NEEDLE WHICH RESULTED IN SEPARATION OF THE DISTAL PORTION OF THE WIRE DURING THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21977274 ↗
• MalfunctionDec 4, 2023Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH A MINI STICK MAX 5F X 10CM STD .018 SS/SS ECHO 2.75" PG. DURING A PROCEDURE, PART OF THE MICROPUNCTURE SEARED OFF, INSIDE OF THE PATIENT, DURING WITHDRAWAL. THE FRAGMENT DID NOT REQUIRE THE USE OF A SNARE TO REMOVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WAS NO REPORT OF PATIENT HARM. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER DETAILS; HOWEVER, THIS HAS BEEN UNSUCCESSFUL.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255296 ↗
• InjuryOct 3, 2019Fracture; Fracture

  AS REPORTED: WIRE TIP OF THE GUIDEWIRE FROM AN ANGIODYNAMICS' ACCESS KIT BROKE DURING VASCULAR ACCESS AND WAS RETAINED INSIDE OF TE PATIENT. 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 9152521 ↗
• InjuryMay 31, 2018Material Fragmentation; Uncoiled; Material Fragmentation; Uncoiled

  PER USER MEDWATCH MW5076679: " PATIENT WAS HAVING CARDIAC CATHETERIZATION WHEN THE RIGHT FEMORAL ARTERY ACCESS WAS ATTEMPTED WITH MICRO PUNCTURE KIT. MICRO PUNCTURE WIRE UNRAVELED AND BECAME STUCK IN THE PATIENT'S GROIN. DR. ATTEMPTED TO PULL WIRE OUT UNDER X-RAY AND WIRE KEPT UNRAVELING AND BROKE OFF. DR. WAS ABLE TO RETRIEVE WIRE AND HOLD WITH HEMOSTAT. SURGEON ATTEMPTED TO REMOVE WIRE AND PATIENT WAS TAKEN TO THE OPERATING ROOM FOR CONTROLLED REMOVAL OF THE REMAINING WIRE. THE WIRE WAS SUCCESSFULLY REMOVED."

  Patient problems: Foreign Body In Patient

  MAUDE report 7556239 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132713. One submission often covers many models, so check the product and lot details in each record.

• Z-1336-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-751
• Z-1343-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765
• Z-1347-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-776
• Z-1346-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775
• Z-1342-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-762
• Z-1344-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-767
• Z-1348-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781
• Z-1338-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754
• Z-1335-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750
• Z-1339-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
• Z-1341-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759
• Z-1345-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774
• Z-1337-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-752
• Z-1340-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-758
• Z-1334-2024 · Jan 30, 2024 · Open, Classified
  MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-749