Surgical Guidewire Introducer Sheath Recalled for Internal Manufacturing Defects
Angiodynamics vascular guidewire introducers (600 units) may have internal defects preventing proper function during surgery. Defects could cause procedure delays and require device exchange.
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: Class II medical device with a manufacturing defect that impairs device functionality during surgery. While no injuries are reported, the defect presents a risk of harm through procedure delays and required mid-surgery device exchange, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Angiodynamics, Inc. is recalling the MINI STICK MAX 4F X 10 CM STIFF guidewire introducer sheath (Catalog Number 45-762). A total of 600 units are affected worldwide, distributed throughout the United States and internationally.
The recalled introducers may contain voids in the internal lumen of the sheath hub. This manufacturing defect can prevent the guidewire from passing through the introducer hub during surgical procedures.
When a guidewire cannot pass through the introducer, it can cause delays in the surgical procedure and require the surgeon to exchange the sheath to complete the vascular surgery case.
Affected lot numbers are 5788541, 5789982, 5791594, 5794608, 5797468, and 5798845. Healthcare facilities should identify any affected units and discontinue use pending receipt of replacement stock.
The recalled product
- Product
- MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-762
- Manufacturer
- Angiodynamics, Inc.
- Affected units
- 600
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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