Nipro AquaLiner Hydrophilic Guidewires Recalled for Insufficient Lubricity
Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes them 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 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: The recall is classified as FDA Class II. The hazard involves a medical device becoming nonfunctional during a procedure, which presents a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Nipro Medical Corporation is recalling its AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/Stiff. The 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 wires contain insufficient lubricity, which causes them to get stuck in the housing and become nonfunctional. The agency has classified this as a Class II recall.
A total of 1,500 units 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. The affected item code is AL+60000103, and the specific lot numbers are 11E27, 11F27, 11H22, 11I19, 11J24, 12B03, 12B09, and 12D09. Healthcare providers should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ 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
- Hazard
- Affected units
- 1,500
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 (8)
- Item Code: AL+60000103 Lot #: 11E27
- 11F27
- 11H22
- 11I19
- 11J24
- 12B03
- 12B09
- 12D09
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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