Angiodynamics surgical guidewire recalled for manufacturing defect
Angiodynamics is recalling 5,176 units of MINI STICK MAX guidewires due to manufacturing voids that prevent passage through the introducer during surgery. Surgeons may need to exchange the sheath to complete procedures.
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: Class II device with manufacturing defect affecting 5,176 units. No injuries reported and the stated consequence is procedural delay requiring equipment exchange, not patient injury.
Plain-English summary
Angiodynamics, Inc. is recalling 5,176 units of MINI STICK MAX 5F X 10 CM surgical guidewires (Catalog Number 45-756) due to a manufacturing defect involving voids in the internal lumen of the sheath hub. This defect can prevent the guidewire from passing through the introducer hub during surgical procedures.
The affected units were distributed worldwide, including throughout the United States and to Austria, Canada, Czech Republic, Hong Kong, Kuwait, Netherlands, New Zealand, Norway, South Africa, and Switzerland. The recall involves 22 specific lot numbers ranging from 5796084 to 5804396.
When voids are present in the sheath hub, the guidewire cannot pass through the introducer as intended. This may cause a delay during the surgical procedure, requiring the surgeon to exchange the sheath to complete the case. No injuries or adverse events have been reported.
The recalled product
- Product
- MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
- Manufacturer
- Angiodynamics, Inc.
- Affected units
- 5,176
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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