Angiodynamics Guidewire Introducer Recall Due to Manufacturing Defect
Angiodynamics recalls approximately 5,840 guidewire introducers with manufacturing defects that may prevent proper guidewire insertion during vascular procedures. The defect could cause procedural delays 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: This is a medical device used in vascular surgical procedures with confirmed manufacturing defects preventing proper function. Although no illnesses or injuries have been reported, the failure during surgical procedures represents a risk-of-harm situation that could cause procedural delays and complications.
Plain-English summary
Angiodynamics, Inc. has recalled MINI STICK MAX 5F X 10 CM STIFF guidewire introducers (Catalog Number 45-759). These medical devices are used to insert guidewires into blood vessels during vascular surgical procedures. Approximately 5,840 units are affected, distributed worldwide including throughout the United States and internationally.
The recalled introducers contain manufacturing defects characterized by voids in the internal lumen of the sheath hub. These voids prevent the guidewire from passing through the introducer hub during surgery as intended. When the guidewire cannot be inserted, surgeons must exchange the device to complete the procedure, causing delays.
Multiple lot numbers are affected and identified in the FDA recall notice. If you are a healthcare provider or facility with inventory of this product, stop using affected units immediately. Contact Angiodynamics, Inc. with your lot numbers for replacement options or further instructions on returning the recalled devices.
The recalled product
- Product
- MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759
- Manufacturer
- Angiodynamics, Inc.
- Affected units
- 5,840
Distribution
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.
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