Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM — Class II medical device recall Z-0499-2014
Terminated recall by Stryker Neurovascular, reported 2013-12-25, distributed nationwide. Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All product
| Recall number | Z-0499-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2013-11-04 |
| Classified | 2013-12-13 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2014-08-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CL, CZ, DE, ES, FR, GB, HK, HU, IN, IT, JP, KR, LT, MY, NL, NO, PL, RU, SK, TR |
| Reason classes | labeling |
| Model numbers | M0031681900 |
Product
Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM, Catalog Number: M0031681900, 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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0499-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.