Nipro AquaLiner Hydrophilic Guidewires Recalled for Insufficient Lubricity
Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes the wires to get stuck in the housing and become nonfunctional.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the defect results in the device becoming nonfunctional rather than causing direct physical injury or death, fitting the criteria for a moderate severity recall involving a functional defect without reported harm.
Plain-English summary
Nipro Medical Corporation is recalling 300 units of AquaLiner Hydrophilic Guidewires (0.035" x 260cm, Straight/Stiff). The recall affects specific lots (11F20, 11I27, 12B10) with Item Code AL+60000003. These guidewires are designed for use in angiographic procedures to introduce and position catheters and interventional devices within the vasculature.
The recall was initiated because the guidewires contain insufficient lubricity. This defect causes the wires to get stuck in the housing, rendering them nonfunctional during use.
The affected products were distributed worldwide, including in the state of New York and the countries of Spain, Germany, Argentina, Panama, Mexico, Chile, Colombia, Ecuador, Peru, and Brazil. Healthcare facilities and distributors should stop using the affected guidewires and contact Nipro Medical Corporation for instructions on return or replacement.
The recalled product
- Product
- AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
- Manufacturer
- Nipro Medical Corporation
- Affected units
- 300
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 (3)
- Item Code: AL+60000003 Lot #: 11F20
- 11I27
- 12B10
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by Nipro Medical Corporation 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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