The Recall Desk
ModerateFDA (Devices)·Z-0499-2014·Announced 2013-12-25

Stryker Neurovascular Microcatheters Recalled for Shelf-Life Labeling Errors

Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with 'use by' dates exceeding 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 involves a labeling error regarding shelf-life data without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Stryker Neurovascular is recalling specific lots of EXCELSIOR SL-10 PRE-SHAPED 45 150CM microcatheters, Excelsior SL-10/Excelsior 1018 Microcatheters, GDC 10, 18 Coils, GDC 18-Fibered VortX Shape Coils, and TransForm Occlusion Balloon Catheters. The recall is due to products being 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 specific lot codes involved are 17026849, 17026939, 17026984, and 17026974.

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 that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM, Catalog Number: M0031681900, Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcathete

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 (4)

  • 17026849
  • 17026939
  • 17026984
  • 17026974

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 →