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AngioDynamics 45758Recalls & 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965457580), received between Feb 25, 2019 and Feb 25, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Crack” (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

  • Crack1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • InjuryFeb 25, 2019Crack; Crack

    AS REPORTED, "DURING A BRACHIOCEPHALIC FISTULA DECLOT, WHEN ADVANCING THE STAINLESS/PALLADIUM WIRE, THE PALLADIUM TIP BROKE OFF AND LODGED IN THE PATIENT'S VASCULATURE. THE TIP HAD TO BE SNARED PERCUTANEOUSLY FOR RETRIEVAL. PHOTOS HAVE BEEN PROVIDED AND IT HAS BEEN INDICTED THAT THE USED WIRE WILL BE RETURNED, AS WELL, FOR EVALUATION.

    Patient problems: Foreign Body In Patient

    MAUDE report 8367305 ↗

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

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Sources and updates

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