RecallRadar

FDA Device recall Z-0136-2013

AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular

On 2012-10-31 the FDA classified a Class II recall of AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular by Nipro Medical, citing nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0136-2013
ClassificationClass II
Statusterminated
Initiated2012-07-27
Published2012-10-31
Last updated2026-09-13 11:53 UTC
CompanyNipro Medical
DistributionNY

Product

AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.

Reason

Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.

Identifiers

code_infoItem Code: AL+60000203 Lot #: 11G02

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0136-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.