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AngioDynamics 45785Recalls & reported problems

Navilyst Medical, Inc. · Mini Stick MAX Coaxial Microintroducer Kit · Class 2

All models of AngioDynamics (16)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965457850), received between Mar 7, 2021 and Mar 7, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    AN END USER REPORTED AN ISSUE WITH A MICRO-PUNCTURE KIT. DURING A PROCEDURE, THE TIP OF THE ACCESS WIRE SHEARED OFF DURING VASCULAR ACCESS. THE PHYSICIAN TRIED TO SNARE THE PART OF THE WIRE THAT CAME OFF BUT WAS UNSUCCESSFUL. NO FURTHER INFORMATION WAS PROVIDED. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO REPORT OF PERMANENT PATIENT HARM OR INJURY.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 11429666 ↗

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

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Sources and updates

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