Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1344-2024·Announced 2024-03-27

Guidewire Introducer Sheath with Manufacturing Defect Recalled by Angiodynamics

Angiodynamics is recalling MINI STICK MAX guidewire introducer sheaths due to manufacturing defects that may prevent guidewire passage. The defect may cause procedural delays requiring equipment exchange during vascular interventions.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II device with manufacturing defects in the sheath hub lumen that may prevent guidewire passage. No illnesses, injuries, or deaths reported. The stated hazard is operational (procedural delay requiring equipment exchange) rather than direct patient harm, meeting criteria for Moderate severity.

Plain-English summary

Angiodynamics, Inc. is recalling the MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG guidewire introducer sheath (catalog number 45-767). This device is used to percutaneously introduce a guidewire into the vascular system during interventional procedures. The recall involves 200 units distributed worldwide.

The recalled sheaths contain manufacturing defects in the form of voids within the internal lumen of the sheath hub. These voids may prevent the guidewire from passing through the introducer hub during a surgical procedure. If a guidewire cannot pass through, the procedure may be delayed and the user may need to exchange the sheath in order to complete the case.

The affected product has been distributed worldwide, including throughout the United States and in Austria, Canada, Switzerland, Czech Republic, Spain, Hong Kong, Kuwait, Netherlands, Norway, New Zealand, and South Africa. Affected lot numbers are 5787806, 5790679, 5795962, 5803521, and 5806728. Healthcare facilities with affected inventory should contact Angiodynamics, Inc. regarding this recall.

The recalled product

Product: 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
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Vascular Intervention
Hazard: manufacturing-defect
device-malfunction
Affected units: 200

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