AngioDynamics 45748Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H965457480), received between Oct 23, 2023 and May 7, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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.

• InjuryMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AND ISSUE WITH A MINI STICK MAX 4F X 10 CM STD .018 SS/SS ECHO 2.75" PG. DURING A PROCEDURE, THE GUIDEWIRE SHEERED WHEN REMOVING AND PART OF THE GUIDEWIRE REMAINED IN THE ACCESS VEIN OF THE PATIENT. THE PATIENT REQUIRED SURGERY TO REMOVE THE FRAGMENT. DESPITE MULTIPLE REQUESTS, NO FURTHER DETAILS HAVE BEEN OBTAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19258760 ↗
• InjuryMar 4, 2024Fracture; Detachment of Device or Device Component; Material Twisted/Bent; Fracture; Detachment of Device or Device Component; Material Twisted/Bent

  A RISK MANAGER REPORTED AN ISSUE WITH A MINI STICK MAX 4F X 10 CM STD .018 SS/SS ECHO 2.75" PG. A PATIENT WAS SCHEDULED FOR A MEDIPORT PLACEMENT. INTERVENTIONAL RADIOLOGY (IR) PHYSICIAN NOTICED A KINK IN THE SHEATH OF THE ANGIODYNAMICS MICROPUNCTURE SET, EXCHANGED IT TO A NEW SET AND COMPLETED THE PROCEDURE. FLUOROSCOPY OF THE PATIENT'S CHEST WAS PERFORMED AND POST PROCEDURE IMAGES SHOWED A FOREIGN OBJECT ON PATIENT'S RIGHT VENTRICLE. A PIECE OF MICROPUNCTURE CATHETER HAD FRAGMENTED AND EMBOLIZED TO THE RIGHT ATRIUM (RA) AND RIGHT VENTRICLE (RV). ENDOVASCULAR RETRIEVAL OF THE CATHETER WAS PERFORMED AND THE OUTER PORTION OF THE MICROPUNCTURE CATHETER WAS SUCCESSFULLY RETRIEVED; HOWEVER, THE INNER PORTION OF THE CATHETER IS STILL RETAINED BETWEEN THE RA AND RV. THE PATIENT WILL BE MONITORED, AS OUTPATIENT, FOR ANY SYMPTOMATIC ARRHYTHMIAS AND FOR ANY WORSENING MITRAL REGURGITATION (MR) WITH ECHOCARDIOGRAM IN 1 MONTH, 3 MONTHS AND 6 MONTHS, PER CARDIOLOGY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827173 ↗
• MalfunctionOct 23, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A MINI STICK MAX 4F X 10CM STD .018 SS/SS ECHO 2.75" PG. DURING A PROCEDURE, THE MICROPUNCTURE WIRE BECAME STUCK AND WAS REMOVED FROM PATIENT. TOWARD THE END OF CASE, IT WAS DISCOVERED THAT PART OF THE MICROPUNCTURE WIRE WAS STILL INSIDE PATIENT. VASCULAR WAS CONSULTED AND THE PATIENT STAYED OVERNIGHT IN THE HOSPITAL FOR OBSERVATION AND WAS THEN DISCHARGED. THE PHYSICIAN IS AN EXPERIENCED USER OF THIS DEVICE AND THE PROCEDURE WAS PERFORMED PER THE IFU; HOWEVER, THE NURSE MANAGER REPORTED BELIEVING THAT THIS WAS NOT A PRODUCT ISSUE BUT RATHER POSSIBLY RELATED TO EITHER CALCIFIED AREAS OF ACCESS OR TECHNIQUE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987340 ↗
• MalfunctionOct 23, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A MINI STICK MAX 4F X 10CM STD .018 SS/SS ECHO 2.75" PG. DURING A PROCEDURE, WHEN THE GUIDEWIRE WAS BEING REMOVED, THE WIRE BECAME STUCK. THE GUIDEWIRE WAS PULLED OUT AND A PIECE OF THE GUIDEWIRE WAS FOUND TO HAVE BROKEN OFF, INSIDE THE PATIENT. VASCULAR AND INTERVENTIONAL CARDIOLOGY WAS CONSULTED TO ASSESS SITE AND DETERMINED THAT NO INTERVENTION WAS NEEDED. THE RIGHT FEMORAL ARTERIAL SHEATH WAS REMOVED AND CLOSED WITH ANGIO-SEAL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS EVENT. THE PHYSICIAN IS AN EXPERIENCED USER OF THIS DEVICE AND THE PROCEDURE WAS PERFORMED PER THE IFU; HOWEVER, THE NURSE MANAGER REPORTED BELIEVING THAT THIS WAS NOT A PRODUCT ISSUE BUT RATHER POSSIBLY RELATED TO EITHER CALCIFIED AREAS OF ACCESS OR TECHNIQUE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987294 ↗

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