AngioDynamics 45751Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H965457510), received between Mar 20, 2024 and Jun 26, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Adverse Event Without Identified Device or Use Problem

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75". IT WAS REPORTED THAT THERE HAVE BEEN SEVERAL CASES IN WHICH THERE WAS VESSEL INJURY DURING INSERTION. ADDITIONALLY, IT WAS REPORTED THAT AT THIS STAGE, THEY WERE UNABLE TO DETERMINE WHETHER THESE INCIDENTS WERE RELATED TO THE ITEM ITSELF OR TO PROCEDURAL AND USER-RELATED FACTORS. IT HAS BEEN DECIDED IN THE RADIOLOGY DEPARTMENT FOR THE ITEM TO BE USED ON THE VEIN AND NOT THE ARTERY.

  Patient problems: Perforation of Vessels

  MAUDE report 25634691 ↗
• MalfunctionApr 4, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  A RISK MANAGER SUBMITTED A USER FACILITY MEDWATCH, REFERENCE (B)(4), FOR A MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG. THE PHYSICIAN WAS ATTEMPTING TO GAIN ACCESS TO RIGHT POPLITEAL VEIN WITH MICROPUNCTURE ACCESS WIRE; HOWEVER, WHEN ATTEMPTING TO REMOVE THE NEEDLE AND WIRE, THE DISTAL END OF THE MICROPUNCTURE WIRE BECAME KNOTTED AND STUCK WITHIN THE ACCESS TRACT. ACCORDING TO THE PATIENT'S MEDICAL RECORD, THE PHYSICIAN ATTEMPTED GENTLE MANIPULATION AND SHALLOW DISSECTION; HOWEVER, THE WIRE SNAPPED BELOW THE SKIN SURFACE, AT THE LEVEL OF THE KNOT. THE SOFT, FLEXIBLE OPAQUE TIP, MEASURING <0.5CM, REMAINED WITHIN THE SKIN TRACT AND WAS UNABLE TO BE RETRIEVED. AT THIS TIME, THERE IS NO KNOWN INJURY TO THE PATIENT AND NO PLANS TO REMOVE THE FRAGMENT AS IT IS NOT POSING ANY ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 21773180 ↗
• MalfunctionMar 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A VASCULAR OR TECHNICIAN REPORTED AN ISSUE WITH A MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG. DURING A TAVR PROCEDURE, A PIECE OF THE MICROPUNCTURE SHEATH/INTRODUCER BROKE OFF INTO THE PATIENT'S FEMORAL VEIN. IT WAS REPORTED THAT THE FRAGMENT WAS DEEMED " TOO HIGH RISK TO REMOVE;" THEREFORE, THE DECISION TO LEAVE IN SITU WAS MADE. AT THIS TIME, THE DEVICE REMAINS WITH THE HOSPITAL'S RISK MANAGEMENT TEAM. THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

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

  MAUDE report 18939417 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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