The Recall Desk
ModerateFDA (Devices)·Z-0512-2014·Announced 2013-12-25

Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates

Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with 'use by' dates that exceed available shelf-life data.

What this means for you

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, and the hazard involves labeling errors regarding shelf-life data without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Stryker Neurovascular is recalling specific medical devices, including the SUPER COMPLIANT 7MM X 15MM microcatheter, Excelsior SL-10/Excelsior 1018 Microcatheter, GDC 10, 18 Coils, GDC 18-Fibered VortX Shape Coil, GDC 18-Fibered VoliX Shape Coil, and TransForm Occlusion Balloon Catheters. The recall was initiated because the products were shipped with 'use by' dates that exceed currently available shelf-life data. All affected products remain within the earliest expiration date of April 2015.

The affected products were distributed worldwide, including nationwide in the United States and internationally to Austria, Belgium, Czech Republic, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia, and Japan. The products are intended to assist in the delivery of diagnostic and therapeutic agents into the peripheral, coronary, and neurovasculature, as well as for endovascular embolization of vascular abnormalities.

Healthcare providers and facilities should stop using the affected products and contact Stryker Neurovascular for further instructions. The recall is classified as Class II by the FDA, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are

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 (1)

  • 17010924

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by Stryker Neurovascular 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.

See all 19 products in this recall →