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U.S. Department of Health and Human Services

Class 2 Device Recall COMPLIANT 4MM X 15MM

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 Class 2 Device Recall COMPLIANT 4MM X 15MMsee related information
Date Initiated by FirmNovember 04, 2013
Date PostedDecember 13, 2013
Recall Status1 Terminated 3 on August 27, 2014
Recall NumberZ-0507-2014
Recall Event ID 66888
510(K)NumberK122576 
Product Classification Catheter, intravascular occluding, temporary - Product Code MJN
ProductStryker brand COMPLIANT 4MM X 20MM, Catalog Number: M003SRC04200; 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.
Code Information 17010968
Recalling Firm/
Manufacturer
Stryker Neurovascular
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information ContactIrene Jaworski
510-413-2500
Manufacturer 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.
FDA Determined
Cause 2
Software Manufacturing/Software Deployment
ActionStryker 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 NeuroComplaints@stryker.com. Or Fax the response form to 1-800-876-4355. For questions regarding this recall call 510-413-2500.
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MJN
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