Guidewire Introducer Sheath Recalled for Internal Lumen Voids
Angiodynamics is recalling 39 units of MINI STICK MAX vascular guidewire introducers due to voids in the sheath hub that may prevent guidewire passage during surgery, potentially delaying the procedure.
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: This is a Class II medical device where a manufacturing defect could delay a critical surgical procedure, requiring equipment exchange. While no reported illnesses or injuries have occurred and the hazard remains theoretical, the device is used in high-risk vascular procedures where delays could pose patient harm.
Plain-English summary
Angiodynamics, Inc. is recalling 39 units of MINI STICK MAX guidewire introducers (Catalog Number 45-781) used for vascular access due to a manufacturing defect.
The recalled introducers from lot numbers 5791593, 5794613, and 5797470 contain voids in the internal lumen of the sheath hub. These voids may prevent the guidewire from passing through during percutaneous vascular procedures.
If the guidewire cannot pass through the introducer hub, the surgical procedure may be delayed and the medical team may need to exchange the sheath to complete the case. This could impact patient care during critical vascular interventions.
The product was distributed worldwide including the United States, Canada, Austria, Switzerland, Czech Republic, Spain, Hong Kong, Kuwait, Netherlands, Norway, New Zealand, and South Africa. Healthcare facilities and medical professionals who have these units should contact Angiodynamics, Inc. for further instructions.
The recalled product
- Product
- MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781
- Manufacturer
- Angiodynamics, Inc.
- Affected units
- 39
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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