Vascular Guidewire Introducer Sheath Recall Due to Manufacturing Defect
Angiodynamics is recalling certain MINI STICK MAX vascular guidewire introducer sheaths due to internal voids that may prevent guidewire passage during surgery, potentially causing procedural delays.
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: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is a manufacturing defect resulting in potential procedural delay requiring equipment exchange, not direct patient harm.
Plain-English summary
Angiodynamics, Inc. is recalling the MINI STICK MAX 5F X 10 CM vascular guidewire introducer sheath (Catalog Number 45-754). The device contains internal voids in the sheath hub that may prevent the guidewire from passing through the introducer during percutaneous vascular procedures. This non-conformance could delay the surgical procedure.
The affected product was distributed worldwide to the US and internationally to Austria, Canada, Switzerland, Czech Republic, Spain, Hong Kong, Kuwait, Netherlands, Norway, New Zealand, and South Africa. A total of 1,676 units are affected across nine identified lot numbers: 5784134, 5787807, 5787808, 5787809, 5787810, 5789980, 5790676, 5800402, and 5803531.
Clinicians and healthcare facilities should inspect affected devices before use and exchange them for functional units if the guidewire does not pass smoothly through the introducer hub. For more information, contact Angiodynamics, Inc. or the U.S. Food and Drug Administration.
The recalled product
- Product
- MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- internal-defect
- procedural-delay
Distribution
Distributed nationwide across the United States.
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