CLASS II Device recall · Reported 25 Dec 2013 · FDA Enforcement Report
Stryker Super Compliant recalled by Stryker Neurovascular
Stryker Neurovascular is recalling Stryker Super Compliant, distributed nationwide in the US. The recall was initiated on 4 Nov 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0512-2014
- FDA event ID
- 66888
- Recalling firm
- Stryker Neurovascular, Fremont, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Nov 2013
- FDA classified
- 13 Dec 2013
- Reported
- 25 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 4 Nov 2013 | Recall initiated by company | |
| 13 Dec 2013 | Classified by FDA | +39 days |
| 25 Dec 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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 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.
Where it was distributed
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
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
17010924
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
18 other products · FDA event 66888This product is part of a recall event; the main page for the event is Stryker Compliant recalled by Stryker Neurovascular.
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