Agency classClass IIOur severity:High FDA (Devices)·Z-1345-2024·Announced 2024-03-27

MINI STICK MAX guidewire introducer defect may prevent sheath passage during procedures

Angiodynamics is recalling MINI STICK MAX guidewire introducers (155 units) due to manufacturing defects in the sheath hub that may prevent guidewire passage.

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 is a Class II vascular access medical device with a manufacturing defect that directly impairs device functionality. While no illnesses or injuries have been reported, this is a risk-of-harm product used in vascular procedures where device performance failures can create procedural complications, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Angiodynamics, Inc. is recalling MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG vascular guidewire introducers (Catalog Number 45-774) due to manufacturing non-conformances affecting the sheath hub.

The recalled introducers may contain voids in the internal lumen of the sheath hub, which can prevent the guidewire from passing through the introducer hub during surgical procedures. When the guidewire cannot pass, the surgical team must exchange the sheath to complete the vascular access procedure, causing delays in treatment.

The recall affects 155 units distributed worldwide, including the United States and Austria, Canada, Switzerland, Czech Republic, Spain, Hong Kong, Kuwait, Netherlands, Norway, New Zealand, and South Africa. The affected lot numbers are 5787804, 5787805, 5800397, 5803524, 5805070, and 5805071.

Healthcare facilities and surgical teams using these introducers should verify the lot number against the recall notice and contact Angiodynamics for guidance on product replacement or return procedures.

The recalled product

Product: 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
Manufacturer: Angiodynamics, Inc.
Category: Medical Device — Vascular Access
Hazard: manufacturing-defect
device-malfunction
Affected units: 155

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