Vascular guidewire introducer recalled for manufacturing defect
Angiodynamics recalls MINI STICK MAX vascular guidewire introducers due to internal lumen defects that may prevent the guidewire from passing through during surgery, potentially requiring device 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: This FDA Class II device recall involves a functional defect that prevents proper use during medical procedures, with potential procedural delay requiring intervention. No injuries or illnesses have been reported, placing this in the high-risk category where harm has not yet occurred.
Plain-English summary
Angiodynamics, Inc. is recalling MINI STICK MAX 4F X 10 CM vascular guidewire introducers (Catalog Number 45-749) due to a manufacturing non-conformance. The devices contain voids in the internal lumen of the sheath hub that may prevent the guidewire from passing through the introducer hub during a surgical procedure.
The affected lot (5805056) comprises 104 units distributed worldwide, including throughout the United States and to Austria, Canada, Switzerland, Czech Republic, Spain, Hong Kong, Kuwait, the Netherlands, Norway, New Zealand, and South Africa.
If the guidewire cannot pass through the introducer during surgery, the procedure may be delayed and the surgeon may need to exchange the sheath to complete the case. Healthcare providers using devices from lot 5805056 should inspect them and contact Angiodynamics for guidance on replacement or proper disposal.
The recalled product
- Product
- MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-749
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- device-malfunction
- manufacturing-defect
- procedural-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 15051684022927 UPN: H965457491 Lot Number: 5805056
Distribution
Distributed nationwide across the United States.
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