Agency classClass IIOur severity:High FDA (Devices)·Z-1340-2024·Announced 2024-03-27

Vascular Guidewire Introducer Recalled Due to Internal Hub Defect

A vascular guidewire introducer is recalled because internal voids in the hub may prevent proper guidewire passage, potentially delaying surgical procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a risk-of-harm medical device used in vascular surgery with no reported hospitalizations or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3.

Plain-English summary

Angiodynamics, Inc. is recalling 15 units of the MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG guidewire introducer due to a manufacturing defect. The device is used to introduce guidewires into the vascular system during percutaneous medical procedures.

The recalled units contain voids in the internal lumen of the sheath hub. These voids may prevent the guidewire from passing through the introducer hub during surgical procedures. If the guidewire cannot pass through, the medical professional may need to exchange the sheath to complete the surgical case, resulting in procedural delays.

The affected units have been distributed worldwide to the United States and the countries of Austria, Canada, Switzerland, Czech Republic, Spain, Hong Kong, Kuwait, Netherlands, Norway, New Zealand, and South Africa. The recalled lot number is 5805060.

Healthcare facilities should verify their current inventory against the affected lot number and ensure no units are used. Affected users should contact Angiodynamics, Inc. for further guidance on replacement or return procedures.

The recalled product

Product: 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
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Vascular Surgery Equipment
Hazard: manufacturing-defect
device-malfunction
Affected units: 15

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

UDI: 15051684023016 UPN: H965457581 Lot Number: 5805060

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 15 recalled by Angiodynamics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

Same manufacturer · Angiodynamics, Inc.

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Same hazard · manufacturing defect