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Terminated

Stryker brand GDC VORTX 2MM X 3MM, Catalog Number: M00335302340; 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 intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.

FDA Recall Z-0504-2014 · Posted 2013-12-13

Recalling FirmStryker Neurovascular
Recall StatusTerminated
Product CodeKRD
Date Initiated2013-11-04
Date Terminated2014-08-27

Reason for Recall

Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.

Firm Action

Stryker Neurovascular sent an Urgent Medical Device Recall letter dated November 4, 2013, all affected users. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and segregate the affected products. Customers with questions were instructed to contact via [email protected]. Or Fax the response form to 1-800-876-4355. For questions regarding this recall call 510-413-2500.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993418FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COILBoston Scientific, Target · 2000-01-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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