Guidewire Introducer Sheath from Angiodynamics Recalled for Manufacturing Defect
Angiodynamics is recalling 65 units of its MINI STICK MAX guidewire introducer sheath due to manufacturing defects that may prevent guidewires from passing through during 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 no reported illnesses or injuries. The hazard is a manufacturing defect causing procedural delays and equipment exchange, not direct patient harm.
Plain-English summary
Angiodynamics, Inc. is recalling 65 units of its MINI STICK MAX 5F X 10 CM guidewire introducer sheath (Catalog Number 45-775), a medical device used for percutaneous introduction of guidewires into the vascular system. The recall affects units with lot numbers 5790680, 5798831, and 5806100.
The sheath hub contains manufacturing defects—specifically, voids in the internal lumen of the sheath hub. These defects may prevent guidewires from passing through the introducer hub during surgical procedures.
The affected device was distributed worldwide, including to the United States and the countries of Austria, Canada, Switzerland, Czech Republic, Spain, Hong Kong, Kuwait, Netherlands, Norway, New Zealand, and South Africa. Healthcare providers should identify recalled units by lot number and cease using them. Contact Angiodynamics, Inc. for guidance on replacement or return of the affected devices.
The recalled product
- Product
- MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775
- Manufacturer
- Angiodynamics, Inc.
- Affected units
- 65
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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