The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1337-2024·Announced 2024-03-27

Guidewire Introducer Recalled for Manufacturing Defect Affecting Device Function

Angiodynamics is recalling 58 units of its MINI STICK MAX guidewire introducer due to voids in the internal lumen that may prevent proper guidewire passage. Users may experience procedural delay requiring device exchange.

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: FDA Class II medical device recall for a vascular intervention device with a manufacturing defect affecting function. This is a risk-of-harm product where injury has not yet been reported, meeting the criteria for High severity.

Plain-English summary

The U.S. Food and Drug Administration is notifying users of a recall involving Angiodynamics' MINI STICK MAX 4F guidewire introducer (Model 45-752). The company identified a manufacturing defect affecting 58 units: voids present in the internal lumen of the sheath hub.

This defect may prevent the guidewire from passing through the introducer hub during surgical procedures. If this occurs, the procedure may be delayed while the clinician exchanges the sheath to complete the case.

The recalled devices were distributed worldwide, including the United States, Austria, Canada, Switzerland, Czech Republic, Spain, Hong Kong, Kuwait, Netherlands, Norway, New Zealand, and South Africa. The affected lot numbers are 5805057 and 5806119.

The recalled product

Product
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
Manufacturer
Angiodynamics, Inc.
Category
Medical Device — Vascular Intervention
Hazard
Affected units
58

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: 15051684022958 U UPN: H965457521 Lot Number: 5805057 5806119

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 →

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