Vascular Guidewire Introducer Sheath Recalled for Internal Hub Defect
Angiodynamics recalls 130 MINI STICK MAX guidewire introducers due to hub voids that may prevent guidewire passage during vascular procedures. No injuries reported.
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 3/5 (High).
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 device with a manufacturing defect (internal hub voids) that prevents normal function (guidewire passage), creating risk of procedural failure and delay during vascular procedures. No injuries have been reported, but the failure mode poses risk to patients requiring vascular access.
Plain-English summary
Angiodynamics, Inc. is recalling 130 units of MINI STICK MAX 5F X 10 CM guidewire introducers (catalog 45-765) due to a manufacturing defect. The affected lot numbers are 5790681, 5795961, 5800479, 5803518, and 5805067.
The device is used to introduce guidewires into the vascular system during interventional procedures. The recall was initiated because voids (gaps) are present in the internal lumen of the introducer hub. These voids may prevent the guidewire from passing through the introducer hub during a surgical procedure.
If a guidewire cannot pass through the introducer, the physician may need to exchange the sheath to complete the procedure. This could result in a delay in treatment. No illnesses or injuries have been reported to date.
The affected product was distributed worldwide, including to the United States and to Austria, Canada, Switzerland, Czech Republic, Spain, Hong Kong, Kuwait, Netherlands, Norway, New Zealand, and South Africa. Healthcare providers should check their inventory and contact Angiodynamics with questions about affected units.
The recalled product
- Product
- MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765
- Manufacturer
- Angiodynamics, Inc.
- Category
- Medical Device — Vascular Access
- Affected units
- 130
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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