Angiodynamics Guidewire Introducer Devices Recalled for Manufacturing Defects
Angiodynamics recalls MINI STICK MAX guidewire introducer devices due to manufacturing defects in the internal lumen that may prevent guidewire passage and delay surgical 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: FDA Class II recall with a manufacturing defect preventing normal device function. No illnesses or injuries have been reported. The primary identified risk is procedural delay requiring device replacement, not direct patient harm.
Plain-English summary
Angiodynamics, Inc. is recalling MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG guidewire introducer devices (Catalog Number 45-750) due to manufacturing defects. The recall affects 4,366 units distributed worldwide, including to the United States and multiple other countries.
The recalled devices may contain voids in the internal lumen of the sheath hub that prevent the guidewire from passing through properly during percutaneous surgical procedures. This defect could cause delays in procedures, requiring healthcare providers to exchange the device to complete the case.
The affected lot numbers are 5784035, 5784036, 5784136, 5787837, 5788554, 5788555, 5789978, 5790448, 5790449, 5791589, 5791590, 5791591, 5797460, 5797461, 5798838, 5799613, 5799623, 5800399, 5804390, and 5806116.
The recalled product
- Product
- MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750
- Manufacturer
- Angiodynamics, Inc.
- Affected units
- 4,366
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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