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.
What this means for you
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.
- Hazard
- manufacturing-defect
- device-malfunction
- procedure-delay
Distribution
Distributed nationwide across the United States.
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