The Recall Desk
ModerateFDA (Devices)·Z-0511-2014·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 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, but the source text indicates a labeling error regarding shelf-life dates without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Stryker Neurovascular is recalling specific medical devices, including the SUPER COMPLIANT 4MM X 7MM 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 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 17010792, 17010836, and 17010880.

Healthcare providers and facilities should check their inventory for these specific catalog numbers and lot codes. If the products are found, they should be removed from use and returned to Stryker Neurovascular or the distributor as instructed. Patients who have already received treatment with these devices should contact their healthcare provider for guidance.

The recalled product

Product
Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number: M003SSC04070; 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 (3)

  • 17010792
  • 17010836
  • 17010880

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 →