Vascular guidewire introducer recalled for manufacturing defect causing procedural delays
Angiodynamics recalls the MINI STICK MAX vascular guidewire introducer due to internal defects in the sheath hub that may prevent guidewire insertion during surgery, potentially requiring equipment exchange.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a surgical vascular access device with a functional defect that may delay procedures. No injuries or illnesses have been reported, placing this in the High category as a risk-of-harm product without reported injury.
Plain-English summary
Angiodynamics, Inc. is recalling the MINI STICK MAX 5F X 15 CM STIFF guidewire introducer (Catalog Number 45-776), which is used to percutaneously introduce a guidewire into the vascular system. The recall involves 40 units distributed worldwide, including to the United States and multiple countries: Austria, Canada, Switzerland, Czech Republic, Spain, Hong Kong, Kuwait, Netherlands, Norway, New Zealand, and South Africa. The affected lot numbers are 5787840, 5803520, and 5805069.
The device is being recalled due to a manufacturing non-conformance: voids in the internal lumen of the sheath hub. These voids may prevent the guidewire from passing through the introducer hub during a surgical procedure. If the guidewire cannot pass through, the user may need to exchange the sheath to complete the procedure.
Healthcare facilities and providers who have received any of the affected units should discontinue their use and contact Angiodynamics for replacement or further guidance.
The recalled product
- Product
- MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-776
- Manufacturer
- Angiodynamics, Inc.
- Category
- Medical Device — Vascular Access
- Hazard
- device-defect
- procedure-delay
Distribution
Distributed nationwide across the United States.
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