FDA Recalls Vascular Guidewire Introducer Due to Manufacturing Defect
Angiodynamics is recalling 959 units of MINI STICK MAX guidewire introducers due to voids in the sheath hub that may prevent proper guidewire placement. Users may experience procedure delays and need to exchange equipment.
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 without reported injuries or illnesses. The manufacturing defect may cause procedural delays requiring equipment exchange, but presents no direct patient harm as described in the source material.
Plain-English summary
Angiodynamics, Inc. is recalling 959 units of MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG guidewire introducers (Catalog Number 45-751), which are used for the percutaneous introduction of a guidewire into the vascular system.
The recalled devices contain voids in the internal lumen of the sheath hub. This manufacturing defect may prevent the guidewire from passing through the introducer hub during surgical procedures, potentially causing delays and requiring healthcare providers to exchange the sheath to complete the case.
The affected devices were distributed worldwide, including throughout the United States and to Austria, Canada, Switzerland, Czech Republic, Spain, Hong Kong, Kuwait, Netherlands, Norway, New Zealand, and South Africa. The recalled lot numbers are 5789981, 5789983, 5791592, 5791595, 5795873, and 5797462.
The recalled product
- Product
- MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-751
- Manufacturer
- Angiodynamics, Inc.
- Affected units
- 959
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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