AngioDynamics 45752Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H965457520), received between Jun 11, 2018 and Dec 3, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 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.

• MalfunctionDec 3, 2021Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A MINI STICK MAX 4F X 10CM. DURING TREATMENT FOR A PATIENT'S DVT IN THE POPLITEAL VEIN, THE INTRODUCER WOULD NOT ADVANCE OVER THE WIRE; THEREFORE, THE ENTIRE DEVICE AND WIRE WERE REMOVED FROM THE PATIENT. IT WAS THEN NOTED THAT THE OUTER DILATOR WAS FRACTURED. IT HAD SPLIT TRANSVERSELY IN HALF, BUT REMAINED ON THE WIRE, SO NO FRAGMENTS WERE RETAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THERE WAS NO APPARENT INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12922968 ↗
• InjuryMar 9, 2020Fracture; Fracture

  A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN UNKNOWN PROCEDURE USING ANGIODYNAMICS' DILATOR/MINISTICK DEVICE. WHILE OBTAINING ACCESS AND ATTEMPTING TO INSERT THE MICROPUNCTURE SHEATH, THE PHYSICIAN HAD EXPERIENCE SOME DIFFICULTY. WHEN REMOVING THE SHEATH FROM THE PATIENT, HE NOTED THE GUIDEWIRE TIP HAD DETACHED AND REMAINED INSIDE OF THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. 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 9805806 ↗
• InjuryJul 11, 2018Crack; Crack

  PER VOLUNTARY MEDWATCH MW5077673, "MICROPUNCTURE WIRE FRACTURED WHILE INSIDE OF PATIENT, REQUIRING INCISION TO REMOVE." THE MEDWATCH INDICATED THAT THE SAMPLE WAS RETAINED BY THE REPORTING HOSPITAL, HOWEVER NO INFORMATION AS TO THE NAME OF NOR CONTACT INFORMATION FOR THE HOSPITAL WAS INCLUDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7677143 ↗
• InjuryJun 11, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  AS REPORTED, ON (B)(6) 2018, A (B)(6) YEAR OLD FEMALE WITH AN EXTENSIVE VASCULAR HISTORY UNDERWENT AN ATTEMPTED CATHETERIZATION USING A MINI STICK MAX VIA LEFT FEMORAL ACCESS. AS THE INTERVENTIONALIST ATTEMPTED TO PULL OUT THE MICROPUNCTURE SHEATH, THE PROXIMAL PORTION SNAPPED OFF LEAVING THE MAJORITY OF THE SHEATH IN SITU. THE RETAINED SHEATH COULD NOT BE VISUALIZED (NOT RADIOPAQUE UNDER FLUOROSCOPY.) THE PATIENT WAS TAKEN TO THE OR FOR A SURGICAL CUTDOWN, PLACEMENT OF A BOVINE PATCH AND SHEATH REMOVAL. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 7587655 ↗

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-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-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-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-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-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-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-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
• 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-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-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-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-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-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-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