Agency classClass IIOur severity:High FDA (Devices)·Z-1347-2024·Announced 2024-03-27

Vascular guidewire introducer recalled for manufacturing defect causing procedural delays

Angiodynamics recalls the MINI STICK MAX vascular guidewire introducer due to internal defects in the sheath hub that may prevent guidewire insertion during surgery, potentially requiring equipment 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 recall of a surgical vascular access device with a functional defect that may delay procedures. No injuries or illnesses have been reported, placing this in the High category as a risk-of-harm product without reported injury.

Plain-English summary

Angiodynamics, Inc. is recalling the MINI STICK MAX 5F X 15 CM STIFF guidewire introducer (Catalog Number 45-776), which is used to percutaneously introduce a guidewire into the vascular system. The recall involves 40 units distributed worldwide, including to the United States and multiple countries: Austria, Canada, Switzerland, Czech Republic, Spain, Hong Kong, Kuwait, Netherlands, Norway, New Zealand, and South Africa. The affected lot numbers are 5787840, 5803520, and 5805069.

The device is being recalled due to a manufacturing non-conformance: voids in the internal lumen of the sheath hub. These voids may prevent the guidewire from passing through the introducer hub during a surgical procedure. If the guidewire cannot pass through, the user may need to exchange the sheath to complete the procedure.

Healthcare facilities and providers who have received any of the affected units should discontinue their use and contact Angiodynamics for replacement or further guidance.

The recalled product

Product: 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
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Vascular Access
Hazard: device-defect
procedure-delay
Affected units: 40

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 · device defect