AngioDynamics 45756Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI H965457560), received between Jun 20, 2019 and May 12, 2020 — classified as 4 injuries, 1 malfunction.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  FDA MEDWATCH REFERENCE MW5093777. A RISK MANAGER REPORTED THAT THIS MINI STICK MAX COAZIAL MICROINTRODUCER KIT WAS USED DURING A CARDIAC CATHERIZATION FOR A ST ELEVATION MYOCARDIAL INFARCTION (STEMI). THE PATIENT MOVED DURING THE PROCEDURE AND WHEN THE CARDIOLOGIST ATTEMPTED TO REMOVE THE WIRE, IT BECAME ENTRAPPED IN THE VESSEL AND A PIECE BROKE OFF AND DISLODGED IN THE SUBINTIMAL SPACE OF THE PATIENT'S EXTERNAL ILIAC ARTERY. WHEN THE CARDIOLOGIST REMOVED THE WIRE, IT WAS NOTICED THAT IT HAD BECOME UNRAVELED AND RESEMBLED A SPRING. VASCULAR SURGERY WAS CONSULTED ABOUT THE FRAGMENT THAT COULD NOT BE REMOVED BUT OPEN SURGERY FOR RETRIEVAL WAS NOT INDICATED. THE VASCULAR SURGEON NOTED THAT BECAUSE THE FRAGMENT IS IN SUBINTIMAL, IT IS UNLIKELY TO REPRESENT AN EMBOLIC SOURCE OR NIDUS. A COVERED STENT WAS ALSO CONSIDERED BUT DETERMINED NOT TO BE NEEDED. THE REPORTED DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10048578 ↗
• InjuryMar 16, 2020Entrapment of Device; Difficult to Remove; Unraveled Material; Device Dislodged or Dislocated

  DURING CARDIAC CATH FOR STEMI, ANGIODYNAMICS MINI STICK MAX COAXIAL MICROINTRODUCER KIT USED, SHEATH 5FX10CM, NEEDLE 70 MM ECHOGENIC, WIRE NITINOL TUNGSTEN, REF 45-756, LOT 5561860, UPN (B)(4), EXP 12/31/2022 USED. PT MOVED DURING THE PROCEDURE AND WHEN CARDIOLOGIST TRIED TO REMOVE WIRE, IT BECAME ENTRAPPED IN THE VESSEL AND ITS FRAGMENT WAS DISLODGED IN SUBINTIMAL SPACE OF EXTERNAL ILIAC ARTERY. CARDIOLOGIST UNABLE TO REMOVE FRAGMENT. WHEN THE WIRE REMOVED (THE REMAINING WIRE NOT THE FRAGMENT), IT WAS NOTED THE WIRE HAD BECAME UNRAVELED AND "LOOKED LIKE A SPRING". VASCULAR SURGERY CONSULTED REGARDING EXTRACTION OF ENTRAPPED WIRE FRAGMENT, HOWEVER, OPEN SURGERY FOR RETRIEVAL NOT INDICATED. PER VASCULAR SURGEON, WIRE FRAGMENT IS SUBINTIMAL AND THEREFORE UNLIKELY TO REPRESENT AN EMBOLIC SOURCE OR NIDUS. COVERED STENT TO THE AREA CONSIDERED BUT DETERMINED NOT TO BE NEEDED. FULL DISCLOSURE TO FAMILY. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9840252 ↗
• InjuryOct 3, 2019Fracture; Fracture

  DURING A PORT PLACEMENT PROCEDURE, THE TREATING PHYSICIAN WAS PLACING A ROUTINE PORT INTO THE PATIENT, ACCESSING THE VEIN USING ANGIODYNAMICS' MICRO INTRODUCER KIT, MINI STICK MAX. AFTER ACCESS WAS GAINED, DR (B)(6) WENT TO REMOVE THE SHEATH/DILATOR AND FOUND THAT THE SHEATH HAD DETACHED FROM THE HUB WHILE INSIDE THE PATIENT. THE SHEATH THEN TRAVELED TO THE PATIENT'S HEART AND ENDED UP IN THE RV. THE SHEATH WAS REMOVED USING A SNARE, AND THE PATIENT IS STABLE AND DOING WELL. 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 9152545 ↗
• InjuryAug 14, 2019Fracture; Fracture

  AS REPORTED: WE HAD AN INCIDENT YESTERDAY. DIFFICULTY ADVANCING WIRE. UNABLE TO ADVANCE OR REMOVED. WHEN FINALLY REMOVED, TIP OF WIRE BROKE OFF AND REMAINED IN PATIENT BODY. IMAGING VERIFIED THAT WIRE PIECE IS NOT IN ARTERY. PIECE REMAINING IN BODY - NOT REMOVED. 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 8893028 ↗
• InjuryJun 20, 2019Fracture; Fracture

  AS REPORTED DURING ACCESS FOR AN ANGIOGRM THE GUIDEWIRE FROM A MINISTICK MAX BROKE OFF INTO THE RIGHT FEMORAL ARTERY. THE PHYSICIAN WAS ABLE TO REMOVE IT ALL IN ITS ENTIRETY WITH NO HARM TO THE PATIENT. THE GUIDEWIRE HAS BEEN RETURNED TO ANGIODYNAMICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8717611 ↗

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-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-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-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-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-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-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-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-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-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-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-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