Z-0512-2014Class II

Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150; Product is manufactured by Stryker...

Name: Z-0512-2014 Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150; Product is manufactured by Stryker...
Creator: Stryker Neurovascular
Published: 2013-11-04
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2013-11-04 / Terminated / root cause: software

FDA source

Stryker Neurovascular began a recall of Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by... on 2013-11-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0512-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-04
Posted: 2013-12-13
Terminated: 2014-08-27
Recalling firm: Stryker Corp.
Product: 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.
Product code: MJN Catheter, Intravascular Occluding, Temporary
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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
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.
Distribution: 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
Product codes and lots: 17010924

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0512-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0494-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0495-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0496-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0497-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0498-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0499-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0500-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0501-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0502-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0503-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0504-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0505-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0506-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0507-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0508-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0509-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0510-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0511-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13
Z-0512-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13

Product code MJN

K122576Class IITransform Occlusion Balloon Catheter (Compliant and Super CompliantStryker Neurovascular / cleared 2013-01-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)